Surgical Face Mask
Device Facts
| Record ID | K202205 |
|---|---|
| Device Name | Surgical Face Mask |
| Applicant | Jiangsu Micsafe Medical Technology Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 9, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Surgical Face Mask is 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
Surgical Face Mask (METH-03) is a flat-pleated, single-use, disposable device; worn by healthcare personnel and patients to provide a barrier against microorganisms, body fluids, and particulates. Device consists of three layers: inner/outer spun-bond polypropylene and middle melt-blown polypropylene filter. Features include steel wire/polypropylene nose piece for fit and spandex/chinlon ear loops for securement. Device is non-sterile; intended for infection control practices. Performance is verified via bench testing against ASTM F2100 Level 3 standards, including bacterial/particulate filtration efficiency and synthetic blood penetration resistance. No clinical data provided.
Clinical Evidence
No clinical data. Safety and effectiveness supported by bench testing: Bacterial Filtration Efficiency (99.65%), Differential Pressure (3.72 mm H2O/cm²), Sub-micron Particulate Filtration Efficiency (99.9%), Synthetic Blood Penetration (160 mmHg), and Flammability (Class 1). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Technological Characteristics
Three-layer construction: spun-bond polypropylene (inner/outer) and melt-blown polypropylene (filter). Nose piece: steel wire/polypropylene. Ear loops: spandex/chinlon. Dimensions: 17.5cm x 9.5cm. ASTM F2100 Level 3 performance. Biocompatibility per ISO 10993-5 and ISO 10993-10. Non-sterile, single-use, disposable.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.
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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March 9, 2021
Jiangsu Micsafe Medical Technology Co., Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202205
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 27, 2021 Received: February 5, 2021
Dear Cassie Lee:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (OS) 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 medical devices and radiation-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.
Ryan Ortega, PhD Acting 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) K202205
Device Name Surgical Face Mask (Model: METH-03)
#### Indications for Use (Describe)
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel 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 nonsterile.
| Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Research and/or Teaching <input checked="checked" type="checkbox"/> Diagnostic Purposes Only |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary for K202205
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
510(k) Owner's Name: Jiangsu Micsafe Medical Technology Co., Ltd Establishment Registration Number: 3014570560 Address: Xituan Industrial Park, Dafeng District, Yancheng City, Jiangsu Province, China Contact Person: Tony Yang Email: info@micsafe.com
#### Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
# Date of the summary prepared: March 8, 2021
#### 2. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Surgical Face Mask Model Name: METH-03 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
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#### 3. 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, Surqical Common name: Surgical Mask 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
#### 4. Device Description
The Surgical Face Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Surgical Face Mask around the nose.
The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-
phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter.
Ear loops, which is held to cover the users' mouth and nose by two Spandex elastic cord and chinlon ultrasonic welded to the Surgical Face Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Surgical Face Mask is in the middle layer of Surgical Face Mask to allow the user to fit the Surgical Face Mask around their noses, which is made of steel wire and polypropylene. The Surgical Face Mask is sold non-sterile and is intended to be single use, disposable device.
The dimensions of each Surgical Face Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 115±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
### 5. Intended Use / Indications for Use
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The Surgical Face Mask is 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.
# 6. Test Summary
Surgical Face Mask (Model: METH-03) has been evaluated the safety and performance by lab bench testing as following:
- 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)
- 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 F2100 Standard Specification For Performance Of Materials Used In Medical Face Masks
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- 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 Part 1610 Standard for the Flammability of Clothing ●
- EN 14683: 2019, Annex C Medical face masks - Requirements and test methods
# 6.1 Summary of Non-Clinical Tests Performed:
- Performance Testing summary
| Test item<br>(Performance<br>Level 3) | Test method | Pass criteria | Test results<br>/Verdict |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------|
| Bacterial filtration<br>efficiency | ASTM F2101-14 Standard<br>Test Method for Evaluating<br>the Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, Using a<br>Biological Aerosol of<br>Staphylococcus aureus<br>according to ASTM<br>F2100:2019 | $\ge$ 98% | 99.65% / Pass |
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| Differential<br>pressure (Delta-P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test methods<br>according to ASTM F2100:2019 | <6.0 mm<br>H2O/cm² | 3.72 mm<br>H2O/cm² /<br>Pass |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------|
| Sub-micron<br>particulate filtration<br>efficiency<br>at 0.1 µm of<br>Polystyrene Latex<br>Spheres | ASTM F2299-03 Standard<br>Test Method for Determining<br>the Initial Efficiency of<br>Materials Used in Medical<br>Face Masks to Penetration by<br>Particulates Using Latex<br>Spheres according to ASTM<br>F2100:2019 | ≥ 98% | 99.9% / Pass |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in mm Hg<br>for pass result | ASTM F1862/F1862M-17<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to<br>ASTM F2100:2019 | Fluid resistant<br>claimed<br>at 160 mm Hg | Fluid Resistant<br>claimed at 160<br>mm Hg<br>/ Pass |
| Flame spread | 16 CFR Part 1610 Standard<br>for the Flammability of<br>Clothing according to ASTM | Class 1 | Class 1 / Pass |
#### ● Biocompatibility Testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
1) In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
2) Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization,
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3) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
# 6.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
# 7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Jiangsu Micsafe Medical<br>Technology Co., Ltd | 3M Health Care | -- |
| 510 (k) | K202205 | K191355 | -- |
| Trade Name | Surgical Face Mask | 3M™ High Fluid-Resistant<br>Surgical Mask and 3M™ High<br>Fluid-Resistant<br>Procedure Mask | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21<br>CFR878.4040) | Class II Device, FXX (21<br>CFR878.4040) | Same |
| Intended use | The Surgical Face Mask is<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material. These<br>face masks are intended for use<br>in infection control practices to<br>reduce potential exposure to<br>blood and body fluids. The face | The 3M™ High Fluid-Resistant<br>Surgical Mask and 3M™ High<br>Fluid-Resistant Procedure Mask<br>is intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids,<br>and particulate material. These<br>face masks are intended for use<br>in infection control practices to<br>reduce potential exposure to | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| | mask is single use, disposable device, provided non-sterile. | blood and body fluids. The face mask is single use, disposable device, provided non-sterile. | |
| Material | | | |
| Outer facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | steel wire and polypropylene | Polyethylene coated steel wire | Similar<br>Note 1 |
| Ear loops | Spandex elastic cord and<br>chinlon | Spandex elastic cord<br>(polyurethane core with<br>polyethylene terephthalate<br>/nylon cover) | Similar<br>Note 1 |
| Design<br>features | Color: Blue (Outer)<br>Ear loops | Color: Green (Outer)<br>Ear loops | Different<br>Note 2 |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification<br>and<br>Dimension | Length: $17.5cm±1cm$<br>Width: $9.5cm±1cm$ | Length: $17.5cm±0.5cm$<br>Width: $9.0cm±0.75cm$ | Similar<br>Note 2 |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100<br>Level | Level 3 | Level 3 | Same |
| Fluid<br>Resistance<br>Performance | Pass at 160 mmHg | 32/32 Passed at 160mm Hg<br>ASTM F1862 | Same |
| Particulate<br>Filtration<br>Efficiency | Passed at ≥98% | 32/32 Passed at ≥98% @ 0.1<br>micron<br>ASTM F2299 | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Bacterial<br>Filtration<br>Efficiency | Passed at $≥98%$ | 31/32 Passed at $≥98%$<br>ASTM F2101 | Same |
| Differential<br>Pressure | Passed at <5 mmH2O/cm² | 32/32 Passed at <5 mmH2O/cm²<br>MIL-M36954C | Same |
| Flammability | Class 1 | 5/5 Passed $≥3$ Seconds burn time - Class 1<br>CFR 16 1610 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the<br>study, the subject device extract<br>was determined to be non-<br>cytotoxic. | Non-cytotoxic. | Same |
| Irritation | Under the conditions of the<br>study, the subject device non-polar and polar extracts were<br>determined to be non-irritating. | Non-irritating. | Same |
| Sensitization | Under the conditions of the<br>study, the subject device non-polar and polar extracts were<br>determined to be non-<br>sensitizing. | Non-sensitizing. | Same |
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# Comparison in Detail(s):
Note 1:
Although the "Ear loops" and "Nose piece" of subject device are a little different from the predicate device, the subject device meets the requirement of standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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# Note 2:
Although the "Design features "and "Specification and Dimension" of subject device are a little different from the predicate device, the subject device meets the requirements of essential performance standard ASTM F2100 and ISO 10993. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
#### 8. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device Surgical Face Mask in 510(k) K202205, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K191355.
