Medical Surgery Mask, Model:2626-7
Device Facts
| Record ID | K220067 |
|---|---|
| Device Name | Medical Surgery Mask, Model:2626-7 |
| Applicant | Dongguan Missadola Technology Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Aug 30, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The medical surgery mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Story
Medical surgery mask (Model 2626-7) is a single-use, disposable, non-sterile, flat-pleated, three-layer face mask. It features an outer layer of spun-bonded polypropylene, a middle melt-blown polypropylene filtration layer, and an inner spun-bonded polypropylene layer. The mask includes a malleable aluminum nose piece and spandex elastic ear loops. It is designed to cover the user's nose and mouth to provide a physical barrier against microorganisms, body fluids, and particulates. The device is intended for use by healthcare personnel and patients in clinical settings to support infection control. It meets ASTM F2100 Level 3 performance requirements for fluid resistance, bacterial filtration efficiency, and particulate filtration efficiency.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100 Level 3 standards, including Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN 14683), Sub-micron Particulate Filtration Efficiency (ASTM F2299), Synthetic Blood Penetration (ASTM F1862), and Flammability (16 CFR 1610). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization).
Technological Characteristics
Three-layer pleated mask. Materials: Spun-bonded polypropylene (outer/inner), melt-blown polypropylene (filter), malleable aluminum wire (nose piece), spandex (ear loops). Dimensions: 175x95mm. Performance: ASTM F2100 Level 3. Non-sterile, single-use. No electronic components or software.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during 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
- Surgical Mask (K202424)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
August 30, 2022
Dongguan Missadola Technology Co., Ltd % Doris Chen Regulatory Affairs Staff Shanghai Jiushun Enterprise Management Technology Service Co.,Ltd Room 1502, BaoAn Buiding, No.800 Dongfang Road Shanghai. 200122 China
Re: K220067
Trade/Device Name: Medical Surgery Mask, Model:2626-7 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 29, 2022 Received: July 29, 2022
Dear Ms. Chen:
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.
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
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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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220067
Device Name MEDICAL SURGERY MASK Model:2626-7
### Indications for Use (Describe)
The medical surgery mask mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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# K220067
# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of 21 CFR 807.92.
The assigned 510(k) Number:K220067
Summary Prepared Date:July 29, 2022
#### 1. Applicant :
Company Name:Dongguan Missadola Technology Co., LTD
Establishment Registration Number:3020729769
Address:F4,bloc 1,No.289,Nanhuang Road,Zhongtang Town, Dongguan city,China.
Contact Person (including title): Adeline Hong(General Manager)
Phone:+86-769-88878117
Email:adeline@missadola.com
## 2. Submission Correspondent:
Contact Person: Doris Chen
Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.
Address: Room 1502,BaoAn Buiding,No.800 Dongfang Road,Shanghai,China.
Tel: +86-21-50931939
Email: doris-chen@isosh.com
#### 3. Subject Device Information
| Type of 510(k): | Traditional |
|----------------------|------------------------------------|
| Common Name: | FaceMask |
| Trade Name: | MEDICAL SURGERY MASK: Model 2626-7 |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
K220067 510(k) Summary Page 1 of 7
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Regulation Class:
#### Predicate Device Information 4.
=
### Predicate Device
| Sponsor: | Foshan Xinbao Technology Co., Ltd. |
|--------------------|------------------------------------|
| Common Name: | Surgical apparel |
| Trade Name: | Surgical Mask |
| 510(k) number: | K202424 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
#### 5. Device Description
The medical surgery mask is pleated three-layer mask with ear loops and nose piece. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric. The medical surgery mask is only the outer layers' color is blue (colorant: Pigment Blue 15:3/Model:147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgery mask.The inner layer is white. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgery mask is in the middle layer of medical surgery mask to allow the user to fit the medical surgery mask around their noses, which is made of malleable aluminum wire.
The dimensions of each medical surgery mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 120±10 mm, and the ear loop is length 180±10 mm. The mask model 2626-7 meets level 3 performance requirements in ASTM F2100.The medical surgery masks are sold non-sterile and are intended to be single use,disposable devices.
> K220067 510(k) Summary Page 2 of 7
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#### Intended Use / Indications for Use 6.
The medical surgery mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
### 7. Comparison with predicate device
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------|
| Manufacturer | Dongguan<br>Missadola<br>Technology Co., LTD | Foshan Xinbao Technology<br>Co., Ltd. | -- | |
| Product Name | MEDICAL SURGERY MASK | Surgical Mask | -- | |
| K Number | K220067 | K202424 | -- | |
| Product Code | FXX | FXX | Same | |
| Regulation<br>Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Intended use/<br>Indications for Use | The medical surgery masks are<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>masks are intended for use in<br>infection control practices to<br>reduce the potential exposure<br>to blood and body fluids. This is<br>a single use, disposable<br>device(s), provided non-sterile. | The Surgical Masks are<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These masks are<br>intended for use in<br>infection control practices to<br>reduce potential exposure<br>to blood and body fluids.<br>This is a single use,<br>disposable device, provided<br>nonsterile. | Same | |
| Mask style | Flat pleated, 3 layers. | Flat pleated,3 layers. | Same | |
| Design feature | Ear loop | Ear loop | Same | |
| Material | Outer<br>facing<br>layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle<br>layer | Melt blown polypropylene filter | Melt blown polypropylene | Same |
| | Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | facing<br>layer | | | |
| | Nose<br>piece | Malleable aluminum wire | Galvanized iron wire | Different<br>Note 1 |
| | Ear<br>loops | Spandex | Nylon and Spandex | Different<br>Note 1 |
| Color | | Blue | Blue | Same |
| Dimension (Width) | | 17.5cm±0.5cm | 17.5cm±1cm | Similar |
| Dimension<br>(Length) | | 9.5cm±0.5cm | 9.5cm±1cm | Similar |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Use | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM<br>Level | F2100 | Level 3 | Level 3 | Same |
| Fluid resistance<br>Performance<br>ASTM F1862 | | 32 out of 32 pass at 160mmHg | Pass at 160mmHg | Same |
| Particle Filtration<br>Efficiency<br>ASTM F2299 | | Lot A: 99.34%<br>Lot B: 99.56%<br>Lot C: 99.33% | Pass at ≥98% | Similar<br>Note 2 |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101 | | Lot A:99.72%<br>Lot B:99.82%<br>Lot C:99.94% | Pass at ≥98% | Similar<br>Note 2 |
| Flammability<br>Class<br>16 CFR 1610 | | Class 1 | Class 1 | Same |
| Differential<br>Pressure<br>(Delta -P)<br>EN 14683 Annex C | | Lot A: 1.86mmH2O/cm²<br>Lot B: 1.87mmH2O/cm²<br>Lot C:1.86mmH2O/cm² | Pass at <6.0 mmH2O/cm² | Similar<br>Note 2 |
| Biocompatibility | | | | |
| Cytotoxicity | | Under the conditions of the study, the device is noncytotoxic. | Under the conditions of the study, the device is noncytotoxic. | Same |
| Sensitization | | Under the conditions of the study, the device is nonirritating. | Under the conditions of the study, the device is nonirritating. | Same |
| Irritation | | Under the conditions of the study, the device is nonsensitizing | Under the conditions of the study, the device is nonsensitizing | Same |
Table 1 General Comparison
K220067 510(k) Summary Page 3 of 7
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### Note 1
The materials of nose piece and the ear loop were different from the predicate device. There are not raise additional questions for safety and effectiveness.
The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements. There is no new risk generated from the difference of the material.
### Note 2
For the Performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 3 medical mask according to the ASTM F2100.
#### 8. Summary of Non-Clinical Tests Performed
Non-clinical tests were conducted to verify that the proposed device met all design specifications as to the predicate device. 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)] Submission issued on March 5, 2004:
- A ASTM F2299-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- > EN 14683:2019,Annex C.Method for determination of breathability (differential pressure)
- > ASTM F1862/ASTM F1862M-17, Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- > ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- > 16 CFR Part 1610, Standard for the flammability of clothing textiles.
- > ISO 10993-5:2009, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
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- A ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Table 2:Performance Testing
| Test item<br>(Performance<br>Level 3) | Proposed device<br>Level 3 | Acceptance criteria<br>Level 3 | Test<br>results<br>/Verdict |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------|-----------------------------|
| Bacterial filtration<br>efficiency (BFE)<br>ASTM F2101-19 | Lot A:99.72%<br>Lot B:99.82%<br>Lot C:99.94% | BFE≥98%. | Pass |
| Differential<br>pressure,(Delta-P)<br>EN 14683:2019,<br>Annex C | Lot A: 1.86mmH2O/cm²<br>Lot B: 1.87mmH2O/cm²<br>Lot C:1.86mmH2O/cm² | Delta-P<6.0H2O/cm² | Pass |
| Sub-micron<br>particulate<br>filltration efficiency<br>at 0.1 micron.<br>ASTM F2299 | Lot A: 99.34%<br>Lot B: 99.56%<br>Lot C: 99.33% | PFE≥98%. | Pass |
| Resistance<br>to<br>penetration<br>by<br>synthetic<br>blood<br>ASTM F1862 | 32 out of 32 per lot pass at 160 mmHg | Fluid resistant claimed at 160 mm Hg | Pass |
| Flame spread<br>16 CFR Part 1610 | Class1 | Class 1 | Pass |
## Results:All tests were passed.
Biocompatibility evaluation and test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and
ISO10993-1:2018 supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- A In Vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices
Part 5: Tests for in vitro cytotoxicity.
- 》 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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- ア Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices—
Part 10: Tests for irritation and skin sensitization.
| Item | Proposed device | Result |
|---------------|-----------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing | Pass |
# 9. Summary of Clinical Performance Test
No clinical study is included in this submission.
## 10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device,
MEDICAL SURGERY MASK is as safe, as effective, and performs as well as or better than the
legally marketed predicate device, Surgical Mask (K202424).
K220067 510(k) Summary Page 7 of 7
