Medical Face Mask

K212471 · Haian Medigauze Co., Ltd. · FXX · Nov 4, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212471
• Device Name: Medical Face Mask
• Applicant: Haian Medigauze Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

Device Story

Medical face mask; flat-pleated, three-layer design. Outer/inner layers: polypropylene; middle layer: melt-blown polypropylene. Includes steel wire nosepiece for fit; spandex/nylon ear loops. Used in clinical settings or by general public for infection control. Protects wearer and patient from blood, body fluids, and particulates. Non-sterile, single-use device.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included Bacterial Filtration Efficiency (≥95%), Sub-micron Particle Filtration Efficiency (≥95%), Differential Pressure (<5.0 mm H2O/cm²), Flammability (Class 1), and Synthetic Blood Penetration (80 mmHg). Biocompatibility testing per ISO 10993-1:2018 confirmed non-cytotoxic, non-irritating, and non-sensitizing.

Technological Characteristics

Three-layer construction: polypropylene outer/inner layers, melt-blown polypropylene middle layer. Steel wire nosepiece. Spandex/nylon ear loops. ASTM F2100-19 Level 1. Non-sterile. Dimensions: 17.5 cm x 9.5 cm.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate materials during infection control practices. Single-use, non-sterile.

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 Face Masks (Ear loops and Tie-on) (K160269)

Submission Summary (Full Text)

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November 4, 2021

Haian Medigauze Co., Ltd Weihua Xu General Manager Jiaoxie Industry Park, Haian Nantong, Jiangsu 226633 China

Re: K212471

Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 30, 2021 Received: August 6, 2021

Dear Weihua Xu:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Clarence W. Murray, III, 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) K212471

Device Name Medical face mask

Indications for Use (Describe)

The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and 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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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

- 1. SUBMITTER
Haian Medigauze Co., Ltd. Jiaoxie Industry Park 226633 Haian, Jiangsu, PEOPLE'S REPUBLIC OF CHINA. Phone: [phone] [phone] Fax:

| Primary Contact Person: | Weihua Xu |
|-------------------------|---------------------------|
| | General Manager |
| | Haian Medigauze Co., Ltd. |
| | Tel: (+86) -13901478762 |
| | Fax: (+86) -513-88240958 |

Date prepared Nov 3, 2021

- 2. DEVICE

| Device name: | Medical Face mask |
|--------------------|-------------------|
| Common name: | Mask, Surgical |
| Regulation number: | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |

#### 3. PREDICATE DEVICE

K160269, Surgical Face Masks (Ear loops and Tie-on).

This predicate has not been subject to a design-related recall.

### 4. DEVICE DESCRIPTION

The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use.

The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose.

The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as follows:

- I Bacterial filtration efficiency (BFE) ≥95%
- . Sub-micron particle filtration efficiency ≥95%
- Differential pressure: <5.0 mm H₂O/cm²

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- I Flammability: class 1
- I Resistance to penetration by synthetic blood: 80 mmHg

## 5. INDICATIONS FOR USE

The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

| | Proposed device | Predicate device | Comparison<br>result |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Haian Medigauze Co., Ltd | SAN-M PACKAGE CO., LTD. | NA |
| 510K Number | K212471 | K160269 | NA |
| Product<br>Common<br>Name | Medical face mask | Surgical Face Masks (Ear<br>loops and Tie-on) | NA |
| Intended Use | The medical face mask is<br>intended to be worn to protect<br>both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>materials in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. It is for single-<br>use and provided non-sterile. | The surgical face masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single-use,<br>disposable device, provided<br>non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design<br>feature | Ear loop | Earloop or tie-on | Similar |
| Material of<br>outer facing<br>layer | Polypropylene | Polypropylene | Same |
| Material of<br>middle layer | Melt blown polypropylene | Polypropylene meltblown<br>and polypropylene spunbond | Similar |
| Material of<br>inner facing<br>layer | Polypropylene | Polypropylene | Same |
| Nosepiece | Polypropylene coated steel<br>wire | Polypropylene coated steel<br>wire | Same |
| Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester,<br>polyurethane<br>Side tapes: Polyester<br>spunbond (ear loops mask) | Similar |
| K212471 | | | |
| | | only)<br>Tie tapes: Polypropylene<br>spunbond or polyester<br>spunbond | |
| Color | Blue | Blue, White | Similar |
| Dimension<br>(Length ×<br>Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm<br>18.0 cm × 9.0 cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F2100<br>level | Level 1 | Level 1 | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the<br>study, the proposed device<br>extract was determined to be<br>non-cytotoxic. | Under the conditions of the<br>study, the proposed device<br>extract was determined to<br>be non-cytotoxic. | Same |
| Irritation | Under the conditions of the<br>study, the proposed device<br>extract was determined to be<br>non-irritating. | Under the conditions of the<br>study, the proposed device<br>extract was determined to<br>be non-irritating. | Same |
| Sensitization | Under the conditions of the<br>study, the proposed device<br>extract was determined to be<br>non-sensitizing. | Under the conditions of the<br>study, the proposed device<br>extract was determined to<br>be non-sensitizing. | Same |

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The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is similar to the predicate device.

### 7. PERFORMANČE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for the medical face mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)

### Performance testing

Performance testing was conducted on the medical face mask. All of the tested

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| Item | Test Methods | Criterion | Result |
|----------------------------------------------------|-----------------------------------------------|------------------|--------|
| Flammability | ASTM F2100-19<br>16 CFR Part 1610-2008 | Class 1 | Pass |
| Bacterial Filtration<br>Efficiency | ASTM F2100-2019 9.1 ASTM<br>F2101-2019 | ≥95% | Pass |
| Different Pressure | ASTM F2100-19 9.2 | < 5.0 mm H2O/cm² | Pass |
| Sub-Micron Particle<br>Filtration Efficiency | ASTM F2100-2019 9.3<br>ASTM F2299/F2299M-2017 | ≥95% | Pass |
| Resistance to<br>Penetration by<br>Synthetic Blood | ASTM F2100-2019 9.4 ASTM<br>F1862/F1862-2017 | Pass at 80 mmHg | Pass |

parameters met the predefined acceptance criteria.

### 8. CLINICAL DATA

No clinical data was included in this submission.

### 9. CONCLUSION

The indications for use statement for the subject device is similar to that of the predicate. The differences between the medical face mask and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the medical face mask should perform as intended in the specified use conditions.

The conclusions drawn from the nonclinical testing demonstrate that the subject device, the Haian Medigauze Medical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed as the predicate device (K160269).