Single-use medical face mask

K201974 · Guangdong Horigen Mother & Baby Products Co., Ltd. · FXX · Mar 7, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201974
• Device Name: Single-use medical face mask
• Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 7, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Single-Use Medical Face Mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

Device Story

Single-use, non-sterile medical face mask; flat-pleated design. Constructed with three layers: outer and inner layers of spun-bond polyethylene; middle layer of melt-blown polyethylene. Features spandex/polyester ear loops and a malleable zinc-strip nose piece for fit. Operates as a self-inhalation filter mask; filters air through mask material during inhalation and exhalation. Used by healthcare workers in clinical settings to provide barrier protection against microorganisms, bodily fluids, and particulates. Output is a physical barrier; healthcare providers use the mask to reduce cross-contamination risk during procedures, benefiting both patient and provider by mitigating exposure to infectious agents.

Clinical Evidence

No clinical data. Bench testing only. Performance testing confirmed compliance with ASTM F2100-19 Level 1 standards: synthetic blood penetration (80 mmHg), PFE (99.8% at 0.1 micron), BFE (99.9%), flammability (Class 1), and differential pressure (2.44 mm H2O/cm2). Biocompatibility testing per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation) confirmed non-cytotoxic, non-sensitizing, and non-irritating results.

Technological Characteristics

Three-layer flat-pleated mask. Materials: spun-bond polyethylene (outer/inner), melt-blown polyethylene (middle). Nose piece: zinc strip. Ear loops: spandex/polyester. Dimensions: 17.5 cm x 9.5 cm. Non-sterile. ASTM F2100 Level 1 performance. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use by healthcare workers during procedures to protect patients and workers against transfer of microorganisms, bodily fluids, and particulate materials.

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

• Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) (K153409)

Submission Summary (Full Text)

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March 7, 2021

Guangdong Horigen Mother & Baby Products Co., Ltd % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9th Floor, R&D Building, No.26 Oinglan Street Panyu District Guangzhou, Guangdong 510006 China

Re: K201974

Trade/Device Name: Single-use medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 29, 2021 Received: February 1, 2021

Dear Olivia Meng:

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 (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 ([e-mail]) or phone [phone] 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) K201974

Device Name Single-use medical face mask

Indications for Use (Describe)

Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is 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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Image /page/3/Picture/0 description: The image shows the logo for HORIGEN. The logo features a red square with rounded corners. Inside the square, there is a white crescent shape with a profile of a face within it. Below the square, the word "HORIGEN" is written in a serif font, with the letters in a light red color.

# 510(k) Summary

### 1. SUBMITTER

Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District, 515100 Shantou, Guangdong, China Phone: [phone] Fax: [phone]

| Primary Contact | Olivia Meng |
|-------------------|-----------------------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service<br>Co., Ltd. |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Changxin Chen |
| Person: | General Manager Assistant |
| | Guangdong Horigen Mother & Baby Products Co., Ltd. |
| | Tel: [phone]-866 |
| | Fax: [phone] |
| Date prepared | March 6, 2021 |
| 2. DEVICE | |
| 510K number | K201974 |
| Device Name: | Single Use Medical Face Mask |

| Device Name: | Single-Use Medical Face Mask |
|-------------------|------------------------------|
| Common name: | Surgical Face Mask |
| Model: | KZ-170A |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |

### 3. PREDICATE DEVICE

K153409, Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

#### DEVICE DESCRIPTION 4.

The proposed device is single-use medical face mask. It is non-sterile and for single use.

The single-use medical face mask is manufactured with three-layers, the inner and

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Image /page/4/Picture/0 description: The image features a logo with a red square background. Inside the square is a white crescent shape with a profile of a face looking towards the right. Below the square, the word "HORIGEN" is written in a red, serif font.

outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip.

It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.

## 5. Indications for use

The single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

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

| | Subject Device | Predicate Device | Comparison<br>Result |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Guangdong Horigen Mother<br>& Baby Products Co., Ltd. | Protect U Guard, LLC | NA |
| 510K Number | K201974 | K153409 | NA |
| Product Common<br>Name | Single-Use Medical Face<br>Mask | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | NA |
| Intended Use | Single-Use Medical Face<br>Mask is intended for use by<br>healthcare workers during<br>procedures to protect both<br>patients and healthcare<br>workers against transfer of<br>microorganisms, bodily<br>fluids, and particulate<br>materials. This device is<br>single-use and provided<br>non-sterile. | Earloop Mask and Tie-On<br>Mask is intended for use by<br>healthcare workers during<br>procedures to protect both<br>patients and healthcare<br>workers against transfer of<br>microorganisms, bodily<br>fluids, and airborne<br>particles. This device is<br>single-use and provided<br>non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Earloop or tie-on | Similar |
| Material of outer<br>facing layer | Spun-bond polyethylene | Spunbound polypropylene | Similar |
| Material<br>of<br>middle layer | Melt blown Polyethylene | Melt blown polypropylene | Similar |
| Material of inner<br>facing layer | Spun-bond polyethylene | Spunbound polypropylene | Similar |
| Nose piece | Malleable polyethylene wire<br>with zinc inside | Aluminum strip | Similar |
| Attachment | Ear loops: Spandex and<br>polyester | Urethane elastic fiber<br>earloop or spunbound<br>polypropylene tie | Similar |
| Dimension<br>(Length × Width) | 17.5 cm × 9.5 cm | 17.7 cm × 9.5 cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100<br>level | Level 1 | Level 1 | Same |
| Resistance to<br>Penetration by<br>synthetic blood | 80 mmHg | 80 mmHg | Same |
| Sub-Micron<br>Particle Filtration<br>Efficiency | Average 99.8% at 0.1<br>micron | 99.18% at 0.1 micron | Similar |
| Bacterial<br>Filtration<br>Efficiency | Average 99.9% | Average 99.17% | Similar |
| Flammability<br>class | 1 | 1 | Same |
| Differential<br>Pressure | Average 2.44 mm H2O/cm2 | Average 3.79 mmH2O/cm2 | Similar |
| Biocompatibility | | | |
| Cytotoxicity<br>ISO 10993-5 | Under the conditions of the<br>study, the device was found<br>non-cytotoxic. | Under the conditions of the<br>study, the device was found<br>non-cytotoxic. | Same |
| Sensitization<br>ISO 10993-10 | Under the conditions of the<br>study, the device was found<br>non-sensitizing. | Under the conditions of the<br>study, the device was found<br>non-sensitizing. | Same |
| Irritation<br>ISO 10993-10 | Under the conditions of the<br>study, the device was found<br>non-irritating. | Under the conditions of the<br>study, the device was found<br>non-irritating. | Same |

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Image /page/5/Picture/0 description: The image features a logo for "HORIGEN". The logo consists of a red square with rounded corners. Inside the square, there is a white crescent shape with a silhouette of two faces looking at each other. Below the square, the word "HORIGEN" is written in a serif font, also in red.

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

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 7.

- 7.1. Non-clinical test performed on the proposed device

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Image /page/6/Picture/0 description: The image shows the logo for HORIGEN. The logo features a red square with rounded corners. Inside the square is a white crescent shape with a profile of a face within it. Below the square, the word "HORIGEN" is written in a sans-serif font.

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

### Biocompatibility testing

The biocompatibility evaluation for the single-use 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 single-use medical face mask. All of the tested parameters met the predefined acceptance criteria.

| Item | Test Methods | Result value | Acceptance criteria |
|---------------------------------------------------------------------------|-------------------------------------------------------|---------------|---------------------|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19<br>ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron Test (%) | ASTM F2100-19<br>ASTM F2299 /ASTM<br>F2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19<br>ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-19<br>16 CFR Part 1610-2019 | NA | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19<br>EN 14683:2019+AC:2019(E)<br>Annex C | Average 2.44 | Level 1: <5.0 |

#### 7.2. Clinical test

No clinical testing was performed.

- 8. CONCLUSION
- 8.1. Clinical test conclusion

No clinical study is included in this submission.

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Image /page/7/Picture/0 description: The image shows the logo for HORIGEN. The logo is a red square with rounded corners. Inside the square is a white image of two faces in profile, facing each other. Below the square is the word "HORIGEN" in a sans-serif font.

### 8.2. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201974, the single-use medical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.