The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
Device Facts
| Record ID | K211771 |
|---|---|
| Device Name | The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask |
| Applicant | The Good Corporation |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Aug 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Story
Single-use, non-sterile surgical masks; four-layer construction (outer non-woven, support, melt-blown filter, inner non-woven). Features ear loops and malleable nosepiece for fit. Used in clinical settings by healthcare personnel and patients to provide barrier protection against microorganisms, body fluids, and particulates. Masks meet ASTM F2100 Level 3 performance requirements for fluid resistance, bacterial filtration efficiency (BFE), and particulate filtration efficiency (PFE).
Clinical Evidence
No clinical data. Bench testing only, including ASTM F2100-19, ASTM F2299 (PFE ≥98%), ASTM F1862 (160 mmHg), ASTM F2101 (BFE ≥98%), EN 14683 (breathability), 16 CFR 1610 (flammability), and ISO 10993 biocompatibility series (cytotoxicity, irritation, sensitization, systemic toxicity).
Technological Characteristics
Four-layer non-woven construction; materials include polypropylene, polyethylene, polyethylene terephthalate, nylon 6, polyurethane, iron, and various colorants (e.g., titanium dioxide, amaranth, tartrazine). Dimensions vary by model (210x85mm or 220x80mm). Performance meets ASTM F2100 Level 3. Non-sterile, single-use, disposable.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce transfer of microorganisms, body fluids, and particulate material, and to reduce exposure to blood and body fluids in infection control practices.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask (K191355)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2022
The GOOD Corporation % Mikael Hellstrand RA Manager K-Bio Solutions 201 South 4th St. Suite 727 San Jose, California 95112
### Re: K211771
Trade/Device Name: The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 20, 2022 Received: July 25, 2022
Dear Mikael Hellstrand:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K211771
#### Device Name
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask
#### Indications for Use (Describe)
The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Name (Model Number):
The GOOD High Fluid-Resistant Surgical Mask (202001629)
The GOOD High Fluid-Resistant Surgical Procedure KF Mask (201703328)
The GOOD Super Guard Design High Fluid-Resistant Surgical Mask (201801049)
The KOEASY High Fluid-Resistant Surgical Mask (202002107)
The KOEASY High Fluid-Resistant Surgical Procedure KF Mask (201905891)
The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask (201905443)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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The assigned 510(k) Number: K211771
# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
## 1. Submitter's Information
Sponsor Name: The GOOD Corporation Address: 47-13 Eoso 3-gil, Cheongbuk-eup, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Postal Code: 17795 Contact Name: Hak Rae Lee Tel: +82-31-684-9812 Fax: +82-31-684-9813 E-mail: hr.lee@thegoodas.com
## Application Correspondent:
Contact Person: Mr. Mikael Hellstrand Company: K-Bio Solutions Address: 201 South 4th St, Suite 727, San Jose, CA95112, USA Tel: USA: 408-750-7843, KOR: +82-10-7103-0993 E-mail: mikael(@)kbiotechsolutions.com
## 2. Date of the summary prepared: August 24, 2022
## 3. Subject Device Information
Type of 510(k): Traditional Trade Name: The GOOD High Fluid-Resistant Surgical Mask The GOOD High Fluid-Resistant Surgical Procedure KF Mask The GOOD Super Guard Design High Fluid-Resistant Surgical Mask The KOEASY High Fluid-Resistant Surgical Mask The KOEASY High Fluid-Resistant Surgical Procedure KF Mask The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask Classification Name: Mask, Surgical Review Panel: General Hospital Product Code: FXX Regulation: 21 CFR 878.4040 - Surgical Apparel Regulatory Class: Class II
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## 4. Predicate Device Information
Sponsor: 3M Health Care Trade Name: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask Classification Name: Mask, Surgical 510(k) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: Class II
## 5. Device Description
The subject device includes six mask models, which are listed in Table 5.0-1 below.
| No. | Device Name | Model<br>Number |
|-----|------------------------------------------------------------------|-----------------|
| 1 | The GOOD High Fluid-Resistant Surgical Mask | 202001629 |
| 2 | The GOOD High Fluid-Resistant Surgical Procedure KF Mask | 201703328 |
| 3 | The GOOD Super Guard Design High Fluid-Resistant Surgical Mask | 201801049 |
| 4 | The KOEASY High Fluid-Resistant Surgical Mask | 202002107 |
| 5 | The KOEASY High Fluid-Resistant Surgical Procedure KF Mask | 201905891 |
| 6 | The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask | 201905443 |
## Table 5.0-1: Subject Device Names and Model Numbers
Each mask is composed of four-layers (outer non-woven layer, support layer, melt blown filter layer, and inner non-woven layer). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The masks are single use, disposable devices, provided non-sterile. These devices are not made from Natural Rubber Latex.
The GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049) share the same dimensions as shown in Table 5.0-2 below. The KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), KOEASY Design Mask (201905443) share the same dimensions as shown in Table 5.0-2 below.
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## Table 5.0-2: Dimensions of the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049), KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), and KOEASY Design Mask (201905443)
| No. | Device Name | Model<br>Number | Dimensions |
|-----|------------------------------------------------------------------|-----------------|----------------------------------------|
| 1 | The GOOD High Fluid-Resistant Surgical Mask | 202001629 | Mask Length: 210mm<br>Mask Width: 85mm |
| 2 | The GOOD High Fluid-Resistant Surgical Procedure KF Mask | 201703328 | |
| 3 | The GOOD Super Guard Design High Fluid-Resistant Surgical Mask | 201801049 | |
| 4 | The KOEASY High Fluid-Resistant Surgical Mask | 202002107 | Mask Length: 220mm<br>Mask Width: 80mm |
| 5 | The KOEASY High Fluid-Resistant Surgical Procedure KF Mask | 201905891 | |
| 6 | The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask | 201905443 | |
The similarities and differences between the six masks in terms of the mask components are provided in Table 5.0-3 below.
## Table 5.0-3: Components of the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), GOOD Design Mask (201801049), KOEASY Surgical Mask (202002107), KOEASY KF Mask (201905891), and KOEASY Design Mask (201905443)
| Component | Component Description | The GOOD<br>High Fluid-<br>Resistant<br>Surgical Mask<br>(202001629) | The GOOD<br>High Fluid-<br>Resistant<br>Surgical<br>Procedure KF<br>Mask<br>(201703328) | The GOOD<br>Super Guard<br>Design High<br>Fluid-Resistant<br>Surgical Mask<br>(201801049) | The KOEASY<br>High Fluid-<br>Resistant<br>Surgical Mask<br>(202002107) | The KOEASY<br>High Fluid-<br>Resistant<br>Surgical<br>Procedure KF<br>Mask<br>(201905891) | The KOEASY<br>Super Guard<br>Design High<br>Fluid-Resistant<br>Surgical Mask<br>(201905443) |
|-----------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Mask<br>Components | Outer Non-Woven Layer | ● | ● | ● | ● | ● | ● |
| | Support Layer | ● | ● | ● | ● | ● | ● |
| | Melt Blown Filter Layer | ● | ● | ● | ● | ● | ● |
| | Inner Non-Woven Layer | ● | ● | ● | ● | ● | ● |
| | Ear String | ● | ● | ● | ● | ● | ● |
| | Nose Support | ● | ● | ● | ● | ● | ● |
| | Colorant (Magenta,<br>Yellow, Cyan, Black) | | ● | ● | | | |
| Polypropylene<br>Melt Blown<br>Filter Density | Polypropylene Melt<br>Blown Filter Density:<br>20mg/m2 | | | ● | ● | | |
| | Polypropylene Melt<br>Blown Filter Density:<br>30mg/m2 | | | | | ● | ● |
= Applicable component that is included in each mask model
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The GOOD Design Mask (201801049) and the KOEASY Design Mask (201905443) share the same components and raw materials as shown in Table 5.0-4 below.
| Table 5.0-4: Identical Components and Raw Materials for both the GOOD Design Mask |
|-----------------------------------------------------------------------------------|
| (201801049) and the KOEASY Design Mask (201905443) |
| No. | Component Name<br>for both the 201801049 and<br>201905443 models. | Raw Material Chemical Name<br>for both the 201801049 and 201905443 models. |
|-----|-------------------------------------------------------------------|----------------------------------------------------------------------------|
| 1 | Outer Non-Woven Fabric | Titanium dioxide |
| | | Polyethylene terephthalate |
| | | Amaranth |
| | | Tartrazine |
| | | Brilliant Blue FCF |
| | | Naphthol Blue Black |
| | | Glycerol |
| 2 | Support Layer | Polyethylene |
| | | Polypropylene |
| 3 | Melt Blown Filter Layer | Polypropylene |
| | | Titanium dioxide |
| 4 | Inner Non-Woven Fabric | Polypropylene |
| | | Polyethylene |
| 5 | Ear String | Nylon |
| | | Nylon 6 |
| | | Carbon Black |
| 6 | Nose Support | Polyurethane |
| | | Polyethylene |
| | | Polyethylene terephthalate |
| | | Iron |
The only difference between the GOOD Design Mask (201801049) and the KOEASY Design Mask (201905443) are identified below as dimensional differences:
- GOOD Design Mask (201801049): Length: 210mm, Width: 85mm ●
- KOEASY Design Mask (201905443): Length: 220mm, Width: 80mm ●
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The GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891) share the same components and raw materials as shown in Table 5.0-5 below.
## Table 5.0-5: Identical Components and Raw Materials for the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891)
| No. | Component Name<br>for the 202001629, 201703328,<br>202002107, and 201905891 models. | Raw Material Chemical Name<br>for the 202001629, 201703328,<br>202002107, and 201905891 models. |
|-----|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 1 | Outer Non-Woven Layer | Titanium dioxide<br>Polypropylene |
| 2 | Support Layer | Polyethylene<br>Polypropylene |
| 3 | Melt Blown Filter Layer | Polypropylene<br>Titanium dioxide |
| 4 | Inner Non-Woven Layer | Polypropylene<br>Polyethylene |
| 5 | Ear String | Nylon 6<br>Polyurethane |
| 6 | Nose Support | Polyethylene<br>Polyethylene terephthalate<br>Iron |
The only difference between the GOOD Surgical Mask (202001629), GOOD KF Mask (201703328), KOEASY Surgical Mask (202002107), and KOEASY KF Mask (201905891) are identified below as dimensional differences:
- GOOD Surgical Mask (202001629): Length: 210mm, Width: 85mm .
- GOOD KF Mask (201703328): Length: 210mm, Width: 85mm ●
- KOEASY Surgical Mask (202002107): Length: 220mm, Width: 80mm ●
- KOEASY KF Mask (201905891): Length: 220mm, Width: 80mm ●
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## 6. Indications for Use
The GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
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# 7. Comparison to Predicate Device
The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
| Comparison<br>Item | Proposed Device | Predicate Device | Note |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Manufacturer | The GOOD Corporation | 3M Health Care | -- |
| 510(k) | K211771 | K191355 | -- |
| Trade Name | • The GOOD High Fluid-<br>Resistant Surgical Mask<br>• The GOOD High Fluid-<br>Resistant Surgical Procedure<br>KF Mask<br>• The GOOD Super Guard<br>Design High Fluid-Resistant<br>Surgical Mask<br>• The KOEASY High Fluid-<br>Resistant Surgical Mask<br>• The KOEASY High Fluid-<br>Resistant Surgical Procedure<br>KF Mask<br>• The KOEASY Super Guard<br>Design High Fluid-Resistant<br>Surgical Mask | 3M™ High Fluid-Resistant<br>Surgical Mask | -- |
| Model | • 202001629<br>• 201703328<br>• 201801049<br>• 202002107<br>• 201905891<br>• 201905443 | • 1835<br>• 1835FS | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Same |
| Product Code | FXX | FXX | Same |
| Indications<br>for Use/<br>Intended Use | The GOOD High Fluid-<br>Resistant Surgical Mask and the<br>KOEASY High Fluid-Resistant<br>Surgical Mask are intended to be<br>worn to protect both the patient | 3M™ High Fluid-Resistant<br>Surgical Mask is intended to be<br>worn to protect both the patient<br>and healthcare personnel from<br>transfer of microorganisms | Same |
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| | and healthcare personnel from | body fluids, and particulate | | | |
|-------------------------------------------|------------------------------------------------------------------|---------------------------------|-----------|--|--|
| | transfer of microorganisms, | material. These face masks are | | | |
| | body fluids, and particulate | intended for use in infection | | | |
| | material. These face masks are | control practices to reduce | | | |
| | intended for use in infection | potential exposure to blood and | | | |
| | control practices to reduce | body fluids. This is a single | | | |
| | potential exposure to blood and | use, disposable device, | | | |
| | body fluids. The face mask is | provided non-sterile. | | | |
| | single use, disposable device, | | | | |
| | provided non-sterile. | | | | |
| | Materials (Model 202001629, 201703328, 202002107, and 201905891) | | | | |
| Outer Non- | Titanium dioxide | Polypropylene Spunbond, | Different | | |
| Woven Layer | Polypropylene | green | Note 1 | | |
| Support | Polyethylene | Polypropylene Spunbond, | Different | | |
| Layer | Polypropylene | white | Note 1 | | |
| Melt Blown | Polypropylene | Polypropylene Meltblown, | Same | | |
| Filter Layer | Titanium dioxide | white | | | |
| Inner Non- | Polypropylene | Polypropylene Thermalbonded, | Different | | |
| Woven Layer | Polyethylene | white | Note 1 | | |
| Nose Support | Polyethylene | Polyethylene Coated Steel | Different | | |
| | Polyethylene terephthalate | Wire | Note 1 | | |
| | Iron | | | | |
| Edge Wrap | Not Applicable | Polypropylene Spunbond, | Different | | |
| | | white or Polyethylene | Note 2 | | |
| | | Terephthalate, white | | | |
| Ear Strings | Nylon 6 | Not Applicable | Different | | |
| | Polyurethane | | Note 1 | | |
| Tie Strings | Not Applicable | Polypropylene Spunbond, | Different | | |
| | | white or Polyethylene | Note 3 | | |
| | | Terephthalate, white | | | |
| Materials (Model 201801049 and 201905443) | | | | | |
| Outer Non- | Titanium dioxide | Polypropylene Spunbond, | Different | | |
| Woven Layer | Polyethylene terephthalate | green | Note 1 | | |
| | Amaranth | | and | | |
| | Tartrazine | | Note 4 | | |
| | Brilliant Blue FCF | | | | |
| | Naphthol Blue Black | | | | |
| | | | | | |
| | Glycerol | | | | |
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| Support<br>Layer | Polyethylene<br>Polypropylene | Polypropylene Spunbond,<br>white | Different<br>Note 1 |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------|
| Melt Blown<br>Filter Layer | Polypropylene<br>Titanium dioxide | Polypropylene Meltblown,<br>white | Same |
| Inner Non-<br>Woven Layer | Polypropylene<br>Polyethylene | Polypropylene Thermalbonded,<br>white | Different<br>Note 1 |
| Nose Support | Polyethylene<br>Polyethylene terephthalate<br>Iron | Polyethylene Coated Steel<br>Wire | Different<br>Note 1 |
| Edge Wrap | Not Applicable | Polypropylene Spunbond,<br>white or Polyethylene<br>Terephthalate, white | Different<br>Note 2 |
| Ear Strings | Nylon<br>Nylon 6<br>Carbon Black<br>Polyurethane | Not Applicable | Different<br>Note 1<br>and<br>Note 4 |
| Tie Strings | Not Applicable | Polypropylene Spunbond,<br>white or Polyethylene<br>Terephthalate, white | Different<br>Note 3 |
| Design Features | | | |
| Colors | Model 202001629,<br>201703328, 202002107, and<br>201905891: White. Model 201801049 and<br>201905443: Magenta,<br>Yellow, Cyan, and Black. | Green (Outer) | Different<br>Note 4 |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple<br>Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterility | | | |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions | | | |
| Length | Model 202001629,<br>201703328, and 201801049:<br>210mm. Model 202002107,<br>201905891, and 201905443:<br>220mm. | 6.9" ± 0.2" (175.26mm ±<br>5.08mm) | Different<br>Note 5 |
| Width | Model 202001629,<br>201703328, and 201801049:<br>85mm. Model 202002107,<br>201905891, and 201905443:<br>80mm. | 3.5" ± 0.3" (88.9mm ±<br>7.62mm) | Different<br>Note 5 |
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets<br>Level 3 | | | |
| Particulate<br>Filtration<br>Efficiency<br>(PFE) | Passed at ≥ 98% @ 0.1 micron<br>(ASTM F2299) | Passed at ≥98% @ 0.1 micron<br>(ASTM F2299) | Same |
| Fluid<br>Resistance | Passed at 160mm Hg<br>(ASTM F1862) | Passed at 160mm Hg<br>(ASTM F1862) | Same |
| Bacterial<br>Filtration<br>Efficiency<br>(BFE) | Passed at ≥ 98%<br>(ASTM F2101) | Passed at ≥98%<br>(ASTM F2101) | Same |
| Differential<br>Pressure | Passed at < 6.0 mm H2O/cm2<br>(EN 14683:2019 Annex C) | Passed at <5 mmH2O/cm2<br>(MIL-M36954C) | Different<br>Note 6 |
| Flammability | Passed: Class 1<br>(16 CFR Part 1610) | Passed ≥3 Seconds burn time -<br>Class 1<br>(16 CFR Part 1610) | Same |
| Biocompatibility | | | |
| In Vitro<br>Cytotoxicity<br>Test<br>ISO 10993-5:<br>2009 | Non-cytotoxic | Non-cytotoxic | Same |
| Skin<br>Sensitization<br>Test<br>ISO 10993-<br>10:2010 | Non-sensitizing | Non-sensitizing | Same |
| Skin<br>Irritation Test<br>ISO 10993-<br>10:2010 | Non-irritating | Non-irritating | Same |
| Systemic<br>Toxicity Test | Non-acute systemic toxicity | Not Applicable | Different<br>Note 7 |
| ISO 10993-<br>11: 2017 | | | |
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Comparison in Detail(s):
## Note 1: Raw Material - Substantial Equivalence Assessments
The patient contacting material for the proposed device is different from predicate device. However, biocompatibility testing per ISO 10993 series standard requirements has been performed on the proposed device and the results does not show any toxicity effect. Performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has also been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in materials is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).
## Note 2: Edge Wrap Component - Substantial Equivalence Assessments
The proposed device does not contain the "Edge Wrap" component of the predicate device. However, the "Edge Wrap" material of the predicate device, "Polypropylene Spunbond, white or Polyethylene Terephthalate, white" is the identical polypropylene or polyethylene terephthalate material that is included in mask layers of the proposed device.
- Without the predicate component of the Edge Wrap, the proposed device was evaluated . with Performance testing with FDA's recognized standard of ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) with all favorable test results showing "pass" with meeting Level 3 requirements.
- As such, the minor difference of not having the "Edge Wrap" is not expected to raise ● different questions of safety and effectiveness compared to the predicate (K191355).
## Note 3: Tie Strings Component - Substantial Equivalence Assessments
The predicate device is available in two types, ear string type and tie string type. The proposed device is provided in only the ear string type. Despite the absence of tie strings, tight securing with ear strings of the proposed device to the user's face. mouth, and nose is achieved as demonstrated with the favorable test results under the FDA's recognized standard of ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks). Thus, this difference is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).
### Note 4: Colors - Substantial Equivalence Assessments
Colors for the proposed device is different from predicate device. However, biocompatibility testing per ISO 10993 series standard requirements has been performed on the proposed device and the results does not show any toxicity effect. Performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has also
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been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in colors is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).
## Note 5: Dimensions - Substantial Equivalence Assessments
Dimensions for the proposed device is different from the predicate device. However, performance testing with ASTM F2100-19 (Standard Specification for Performance of Materials Used in Medical Face Masks) has been performed on the proposed device and the results show "pass" with meeting Level 3 requirements. Thus, this difference in dimensions is not assessed to raise different questions of safety and effectiveness compared to the predicate (K191355).
## Note 6: Differential Pressure - Substantial Equivalence Assessments
The differential pressure test reference used for the proposed device and the predicate device are not the same references; the differential pressure testing for the proposed device was conducted according to "EN 14683:2019 Annex C: Method for Determination of Breathability", while the differential pressure testing for the predicate device was conducted according to "MIL-M36954C: Military Specification-Mask, Surgical, Disposable".
- The differential pressure testing for the proposed device was appropriately completed for . EN 14683:2019 Annex C. The EN 14683:2019 Annex C is the one of the mask performance standards specified in ASTM F2100-19. ASTM F2100-19 is the FDA's recognized consensus standard [FDA Recognition Number 6-425] which is the standard specification for performance of materials used in medical face masks.
- Thus, the standard reference difference of "EN 14683:2019 Annex C (Test Criteria: < 6.0 ● mm H2O/cm²) versus "MIL-M36954C (Test Criteria: < 5.0 mm H2O/cm²)" is not assessed to raise different questions in terms of the safety and effectiveness compared to the predicate device.
## Note 7: Non-acute Systemic Toxicity Testing - Substantial Equivalence Assessments
Non-acute systemic toxicity biocompatibility testing per ISO 10993-11 has been performed on the proposed device and the results does not show any toxicity effect.
- . However, non-acute systemic toxicity biocompatibility testing per ISO 10993-11 was not performed on the predicate device.
- The non-acute systemic toxicity biocompatibility testing per ISO 10993-11 performed on . the proposed device does not raise different questions in terms of the safety and effectiveness compared to the predicate device.
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## 8. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions issued on March 5, 2004:
- > ISO 10993-05:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
- > ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
- > ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
- > ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
- > ASTM F1862, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- > EN 14683, Medical Face Masks Requirements and Test Methods
- > ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
- > ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- > 16 CFR 1610, Standard for the Flammability of Clothing Textiles
| Performance Testing | | | | | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------|--------|--|--|
| Test Methodology | Purpose | ASTM F2100-19<br>Acceptance Criteria:<br>Level 3 Barrier | Result | | |
| Particulate Filtration<br>Efficiency (PFE)<br>ASTM F2299-17 | Measure initial particle<br>filtration efficiency | ≥98% | Passed | | |
| Fluid Resistance<br>ASTM F1862-17 | Evaluate the resistance to<br>penetration by impact of<br>small volume of synthetic<br>blood | Pass at 160 mmHg | Passed | | |
| Bacterial Filtration<br>Efficiency (BFE)<br>ASTM F2101-19 | Measure bacterial filtration<br>efficiency | ≥98% | Passed | | |
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| Differential Pressure<br>(mmH2O/cm2)<br>EN 14683:2019 Annex C | Determine breathability of<br>the mask | <6 mmH2O/cm² | Passed |
|---------------------------------------------------------------|--------------------------------------------|--------------|--------|
| Flammability<br>16 CFR Part 1610-2008 | Response of materials to<br>heat and flame | Class 1 | Passed |
## Biocompatibility Testing
According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Intact Skin Contact and duration of contact is B - prolonged (>24h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Biocompatibility Evaluation | | | |
|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------|--------|
| Test Methodology | Purpose | Acceptance Criteria | Result |
| ISO 10993-5: 2009<br>Biological Evaluation of<br>Medical Devices – Part<br>5: Tests for In Vitro<br>Cytotoxicity. | Verify the Cytotoxicity<br>potential of the subject<br>device | Non-cytotoxic | Passed |
| ISO 10993-10: 2010<br>Biological Evaluation of<br>Medical Devices – Part<br>10: Tests for Irritation<br>and Skin Sensitization. | Verify the Sensitization<br>potential of the subject<br>device | Non-sensitizing | Passed |
| ISO 10993-10: 2010<br>Biological Evaluation of<br>Medical Devices – Part<br>10: Tests for Irritation<br>and Skin Sensitization. | Verify the Irritation<br>potential of the subject<br>device | Non-irritating | Passed |
| ISO 10993-11: 2017<br>Biological Evaluation of<br>Medical Devices – Part<br>11: Tests for Systemic<br>Toxicity. | Verify the Acute Systemic<br>Toxicity potential of the<br>subject device | Non-acute systemic<br>toxicity | Passed |
## 9. Summary of Clinical Testing
No clinical study is included in this submission.
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## 10. Final Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, the GOOD High Fluid-Resistant Surgical Mask and the KOEASY High Fluid-Resistant Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicated device, 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, cleared under K191355.
