Protective Face Mask for Medical Use

K202358 · Hunan Heng Chang Pharmaceutical Co., Ltd. · FXX · Jan 29, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202358
• Device Name: Protective Face Mask for Medical Use
• Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face 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/sterile.

Device Story

Protective Face Mask for Medical Use; flat-folded, three-layer disposable mask. Input: physical barrier against airborne/fluid-borne contaminants. Operation: mechanical filtration via polypropylene layers (spun-bond outer/inner, melt-blown middle). Output: physical protection for wearer and patient. Used in clinical/surgical settings by healthcare personnel. Benefits: reduces potential exposure to blood, body fluids, and microorganisms during procedures. Features conformable nose piece and elastic ear loops; non-sterile or sterile options.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F1862M-17 (fluid resistance: 32/32 pass at 120mmHg), ASTM F2299 (particulate filtration: 98.9-99.9%), ASTM F2101-19 (bacterial filtration: 98.9-99.9%), EN 14683:2019 (differential pressure: 4.0-5.6 mmH2O/cm²), and 16 CFR 1610 (flammability: non-flammable). Biocompatibility confirmed per ISO 10993 series.

Technological Characteristics

Three-layer construction: polypropylene spun-bond (outer/inner), polypropylene melt-blown (middle). Includes conformable nose piece and ultrasonically welded elastic ear loops (latex-free). Flat-fold form factor. Single-use, disposable. Non-sterile or sterile. Complies with ASTM F2100-19 Level 2, ISO 10993, and 16 CFR 1610.

Indications for Use

Indicated for healthcare personnel use during procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.

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

• FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287)

Reference Devices

• N95 Particulate and Surgical Mask, Models TN01-11 and TN01-12 (K160271)

Submission Summary (Full Text)

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January 29, 2021

Hunan Heng Chang Pharmaceutical Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, 200071 China

Re: K202358

Trade/Device Name: Protective Face Mask for Medical Use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 23, 2020 Received: December 28, 2020

Dear Shelley Li:

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

Sincerely.

For CAPT Elizabeth Claverie, M.S. 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) K202358

Device Name Protective Face Mask for Medical Use

#### Indications for Use (Describe)

The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile/sterile.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> ☒ </span> </div> |

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# 510(k) summary: K202358

## I. Submitter

Hunan Heng Chang Pharmaceutical Co., Ltd.

Floor 2,3,102 of Building 16, Standard Plant of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Kaifu District, Changsha 410000, China

Contact person: Tao jingfeng Position: QC Manager Tel.: [phone] E-mail: [e-mail] Preparation date: Dec.23, 2020

# II. Proposed Device

| Trade Name of Device: | Protective Face Mask for Medical Use |
|-----------------------|--------------------------------------|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
| 510(k) Number: | K202358 |

# III. Predicate Devices and Reference Device

### Predicate device

| 510(k) Number: | K143287 |
|-----------------|-------------------------------------------------|
| Trade name: | FLUIDSHIELD Surgical Mask with Expanded Chamber |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer: | Halyard Health, Inc. |

# Reference Device

| 510(k) Number: | K160271 |
|----------------|------------------------------------------------------------------|
| Trade name: | N95 Particulate and Surgical Mask, Models TN01-11 and<br>TN01-12 |
| Common name: | Surgical Respirator |

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| Classification: | Class II |
|-----------------|-------------------------|
| Product Code: | MSH |
| Manufacturer | San-M Package Co., Ltd. |

## IV. Device description

The Protective Face Masks for Medical Use are flat-folded masks are three layers of materials consisting of polypropylene spun-bond (outer layer and inner layer), polypropylene melt-blown (middle layers). The masks contain a conformable nose piece enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, elastic ear loops not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in white.

The Protective Face Masks for Medical Use are single use, disposable device, provided non-sterile/sterile.

## V. Indication for use

The Protective Face Mask for Medical Use is intended to worn by the healthcare personnel during procedure to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These face 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/sterile.

### VI. Comparison of technological characteristics with the predicate devices

| Item | Proposed device<br>(K202358) | Predicate device<br>(K143287) | Reference device<br>(K160271) | Discussion |
|----------------|-----------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|------------|
| Product name | Protective Face Mask<br>for Medical Use | FLUIDSHIELD<br>Surgical Mask with<br>Expanded Chamber | N95 Particulate and<br>Surgical Mask,<br>Models TN01-11 and<br>TN01-12 | - |
| Product Code | FXX | FXX | MSH | Similar |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Class II | Same |

Table 1-Comparison of proposed device and predicate devices

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| Mask style | | Expanded Chamber<br>(Duckbill) Flat-fold,<br>headband ties , 4<br>Layers | Flat-fold, Headband, 4<br>Layers | Similar1 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indication<br>for use | The Protective Face<br>Mask for Medical Use<br>is intended to worn by<br>the healthcare<br>personnel during<br>procedure to protect<br>both the patient and<br>the healthcare<br>personnel from the<br>transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the potential<br>exposure to blood and<br>body fluids. This is a<br>single use, disposable<br>device(s), provided<br>non-sterile/sterile. | The Expanded<br>Chamber Surgical<br>Face Mask is<br>intended to be worn to<br>protect both the<br>patient and healthcare<br>personnel from<br>transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the potential<br>exposure to blood and<br>body fluids. This is a<br>single use, disposable<br>device(s), provided<br>non-sterile. | The N95 Particulate<br>Respirator and<br>Surgical Mask,<br>Models TN01-11 and<br>TN01-12 are single<br>use , disposable<br>devices, provided<br>non-sterile and are<br>intended to be worn<br>by operating room<br>personnel or other<br>healthcare workers to<br>protect both the<br>patient and operating<br>room personnel from<br>of microorganisms,<br>body fluids and<br>particulate material. | Similar to<br>predicate<br>device<br>Different<br>from<br>reference<br>device | |
| Material | Inner<br>layer | Spun-bond<br>polypropylene | Polyethylene/Polyester | Polypropylene and<br>polyethylene | Different2 |
| | Middle<br>layer | Melt blown<br>polypropylene filter | Middle layer #1:<br>Polypropylene<br>Spunbond<br>Middle layer #2:<br>Polypropylene<br>Meltblown | Two filter layers<br>Polypropylene<br>meltblown | Similar |
| | Outer<br>layer | Spun-bond<br>polypropylene | Top Half: Blue<br>Polypropylene<br>Spunbond (w Print)<br>Bottom Half: White<br>Polypropylene | Polypropylene<br>spunbond | Similar |
| | Ear loop/head band | Spandex + Polyester | Polyester Spunlace or<br>Polypropylene<br>Spunbond | Polyurethane, not<br>made with natural<br>rubber latex | Different2 |
| | Nose piece | Outer plastic, inner<br>aluminum wire,<br>Sponge strips | Unknown | Polyethylene coated<br>steel wire | Different2 |
| Offered with Visor | | No | Yes | No | Different |
| Color | | White | Top Half: Blue<br>Bottom Half: White | Orange / White | Different2 |
| Dimensions | | Length: 16cm<br>Width: 20cm | Length: 19cm<br>Width: 21cm | TN01-12 (Small):<br>Length: 205 ± 5 mm<br>Width: 75 ± 5 mm<br>Band length: 205 ± 5 mm<br>TN01-11 (Medium):<br>Length: 240 ± 5 mm<br>Width: 75 ± 5 mm<br>Band length: 240 ± 5 mm | Different3 |
| OTC use | | Yes | Yes | Yes | Same |
| Sterility | | Non-sterile/sterile | Non-sterile | Non-sterile | Different4 |
| For single use | | Yes | Yes | Yes | Same |
| ASTM<br>F2100 Level | | ASTM F 2100-19,<br>Level 2 | ASTM F2100-11,<br>Level 2 | ASTM F2100-11,<br>Level 3 | Similar4 |
| Fluid Resistance<br>Performance | | pass at 120mmHg | pass at 120mmHg | pass at 160mmHg | Same as the<br>predicate device |
| Particulate Filtration<br>Efficiency | | ≥98% | ≥98% | NIOSH Certification<br>#TC 84A-3348<br>(includes TN01-11 &<br>TN01-12) | Same as the<br>predicate device |
| Bacterial | | ≥98% | ≥98% | NIOSH Certification | Same as the |
| Filtration<br>Efficiency | | | #TC 84A-3348<br>(includes TN01-11 &<br>TN01-12) | predicate<br>device | |
| Differential<br>Pressure | <6.0mmH2O/cm² | <5.0mmH2O/cm² | NIOSH Certification<br>#TC 84A-3348<br>(includes TN01-11 &<br>TN01-12) | Similar4 | |
| Flammability | Class I<br>flammable | non | Class I non flammable | Same | |
| Biocompatibility | Confirm to the<br>requirements of ISO<br>10993 series<br>standards | Confirm to the<br>requirements of ISO<br>10993 series<br>standards | Confirm to the<br>requirements of ISO<br>10993 series<br>standards | Same | |

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1 The physical feature of the proposed device has minor difference from the predicate device. But the proposed device has similar mask shape with the reference device, which it is a surgical respirator. Both of them have the similar indications. The conclusion can be drawn out that the different mask style does not affect the indications of the device.

2 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.

3 Compare with the predicate and reference device, the different of the physical feature or size does not affect the intended use of the subject device.

4 The subject device (sterile or non-sterile) has performed performance test according to the ASTM F 2100-19. The test results demonstrate that meet the acceptance criteria.

# VII. Non-Clinical Testing

Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of tests article, which demonstrated that the proposed device complies with the following standards:

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| Methodology | Purpose | Acceptance Criteria | Results |
|--------------------------|--------------------------------------|---------------------------------|---------------------------------|
| ASTM<br>F1862M-17 | Fluid Resistance<br>Performance | 29 out of 32 pass<br>at 120mmHg | 32 out of 32 pass<br>at 120mmHg |
| ASTM F2299 | Particulate<br>Filtration Efficiency | $\geq$ 98% | 98.9~99.9% |
| ASTM F2101-19 | Bacterial Filtration<br>Efficiency | $\geq$ 98% | 98.9~99.9% |
| EN 14683:2019<br>Annex C | Differential<br>Pressure | <6.0mmH2O/cm² | 4.0~5.6<br>mmH2O/cm² |
| 16 CFR 1610 | Flammability | Class I non<br>flammable | non flammable |

- ISO 10993-5: 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.
- ASTM F2100-19, Standard Specification for Performance of Materials Used In ● Medical Face Masks.
- ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face . Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019, Medical Face Mask-Test-Requirements and Test Methods ●
- ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration . Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03. Stand 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: .

# VIII. Clinical Testing

No clinical study is included in this submission.

# IX. Conclusion

The conclusion drawn from the non-clinical performance testing data demonstrates that the subject device is as safe, as effective, and performs as well as the predicate

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device, FLUIDSHIELD Surgical Mask with Expanded Chamber (K143287).