United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

K202697 · United Sewing Automation, Inc. · FXX · May 13, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202697
• Device Name: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
• Applicant: United Sewing Automation, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: May 13, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are 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. These face masks are single-use, disposable devices, provided non-sterile.

Device Story

Disposable, non-sterile, 3-layer face mask; covers nose and mouth. Outer/inner layers: polypropylene spunbound; middle layer: polypropylene melt blown. Features bendable polyethylene-coated wire nosepiece and nylon/spandex ear loops. Used in clinical settings or over-the-counter by general public/healthcare personnel for infection control. Acts as physical barrier against microorganisms, body fluids, and particulates. Protects both wearer and patient. No natural rubber latex.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F1862 (fluid resistance at 160 mmHg), ASTM F2101 (BFE 99.62%), ASTM F2299 (PFE 99.76%), and 16 CFR 1610 (Class 1 flammability). Biocompatibility confirmed per ISO 10993-1, -5, and -10 (non-cytotoxic, non-irritating, non-sensitizing).

Technological Characteristics

3-layer construction: polypropylene spunbound (outer/inner), polypropylene melt blown (filter). Nosepiece: polyethylene-coated wire (10.16 cm). Ear loops: nylon/spandex (12.7 cm). Dimensions: 17.5 cm x 9.5 cm. Non-sterile. Biocompatible per ISO 10993. Flammability Class 1 (16 CFR 1610).

Indications for Use

Indicated for use by patients and healthcare personnel to reduce the transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids in 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

• San-M Package Co., Ltd. Surgical Face Masks (Ear loops and Tie-on) (K160269)

Submission Summary (Full Text)

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May 13, 2021

United Sewing Automation Inc. % Heather Hatcher Regulatory Scientist Womble Bond Dickinson, US LLP One West Fourth Street Winston-Salem, North Carolina 27101

Re: K202697

Trade/Device Name: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 14, 2020 Received: September 16, 2020

Dear Heather Hatcher:

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 and Part 809); 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,

For Clarence W. Murray III, Ph.D. 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) K202697

#### Device Name

United Sewing High Fluid Resistant Disposable Face Mask United Sewing High Fluid Resistant Surgical Mask United Sewing High Fluid Resistant Procedure Mask

#### Indications for Use (Describe)

The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are 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. These face masks are single-use, disposable devices, 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 K202697

| Sponsor Information: | United Sewing Automation, Inc.<br>1772 N. Andy Griffith Parkway<br>Mount Airy, NC 27030 |
|----------------------|-----------------------------------------------------------------------------------------|
|----------------------|-----------------------------------------------------------------------------------------|

- Contact information: Benjamin Web Title: CEO Phone: [phone] Email: [e-mail]
Date of Summary Prepared: May 13, 2021

- Common Name: Surgical Mask
- Classification Name: Surgical Apparel

Proprietary Name: United Sewing High Fluid Resistant Disposable Face Mask United Sewing High Fluid Resistant Surgical Face Mask United Sewing High Fluid Resistant Procedure Face Mask

- Review Panel: General and Plastic Surgery
- Product Code: FXX
- Device Classification: Class II per 21 CFR §878.4040
- San-M Package Co., Ltd. Surgical Face Masks Predicate Device(s): (Ear loops and Tie-on) (K160269)

Intended Use/Indications for Use:

Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are 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 United Sewing High Fluid Resistant

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These face masks are single-use, disposable devices, provided nonsterile.

### Device Description:

The United Sewing High Fluid Resistant Disposable Face Mask is a single use, disposable, nonsterile face mask intended to cover the nose and mouth of the wearer. The subject device consists of 3 layers with the outer and inner layer made with polypropylene spunbound material and middle layer made with polypropylene melt blown material, The device has a bendable nosepiece made with Polyethylene coated single wire, and ear loops made from nylon and spandex material. This device will be provided over the counter under the trade names United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask for marketing purpose. This device is not made with natural rubber latex.

### Comparison of Technological Characteristics between the subject and predicate devices:

Descriptions and comparisons of the United Sewing High Fluid Resistant Disposable Face Mask, and the same face mask that is marketed as the United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask, and predicate device features are presented in the Technological Characteristics Comparison Table.

| Item(s) | Subject Device<br>(K202697)<br>United Sewing High<br>Fluid Resistant<br>Disposable Face Mask,<br>also marketed under<br>trade names United<br>Sewing High Fluid<br>Resistant Surgical Face<br>Mask and United<br>Sewing High Fluid<br>Resistant Procedure<br>Face Mask | Predicate Device<br>(K160269)<br>San-M Package Co.,<br>Ltd. Surgical Face<br>Masks (Ear loops and<br>Tie-on) | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended<br>Use/Indications<br>for Use | The United Sewing High<br>Fluid Resistant<br>Disposable Face Mask,<br>also marketed under<br>trade names United<br>Sewing High Fluid<br>Resistant Surgical Face<br>Mask and United Sewing | The surgical face<br>masks are intended to<br>be worn to protect both<br>the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate | Similar |
| | High Fluid Resistant<br>Procedure Face Mask, is<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. This face mask<br>is intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids. This face<br>mask is a single-use,<br>disposable devices,<br>provided non-sterile. | material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single-use,<br>disposable device,<br>provided non-sterile. | |
| Outer Layer | Polypropylene,<br>Spunbound, 99.5% | Polypropylene | Same |
| Filter (Middle)<br>Layer | Polypropylene, Melt<br>Blown | Polypropylene<br>Spunbond;<br>Polypropylene<br>meltblown | Same |
| Inner Facing<br>Layer | Polypropylene,<br>Spunbound, 99.5% | Polypropylene thermal-<br>bonded | Same |
| Nose Piece | Polyethylene Coated<br>Single Wire, 10.16 cm | Polyethylene coated<br>steel wire | Same |
| Ear Loops | Nylon and Spandex, 12.7<br>cm each side | Polyester, polyurethane | Different* |
| Mask Color | White | Variety colors | Different* |
| Mask Style | Flat pleated | Flat pleated | Same |
| Multiple Layers | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Length | 9.5 cm ± 0.5 cm | 90 mm ± 3 mm<br>92 mm ± 3 mm | Similar |
| Width | 17.5 ± 0.5 cm | 175 mm ± 5 mm<br>180 mm ± 5mm | Similar |
| Particulate<br>Filtration<br>Efficiency (PFE) | 99.76%<br>ASTM F2299 | Pass<br>ASTM F2299 | Similar |
| Fluid Resistance | Pass at 160 mm Hg<br>ASTM F1862 | Pass at 80-160 mm Hg<br>ASTM F1862 | Same |
| Bacterial Filtration<br>Efficiency (BFE) | 99.62%<br>ASTM F2101 | Pass at ≥98% | Same |
| | | ASTM F2101 | |
| Differential<br>Pressure | 4.8 mm H2O/cm²<br>EN 14683:2019 and<br>ASTM F2101-19 | Pass at ≤2.5 H2O/cm²<br>MIL-M36945C | Same |
| Flammability | Class 1, 16 CFR 1610 | Class 1, 16 CFR 1610 | Same |
| Biocompatibility | Non-cytotoxic, non-<br>irritating, and non-<br>sensitizing | Non-cytotoxic, non-<br>sensitizing, non-<br>irritating | Same |
| *Although the ear loop materials and color subject device are little difference with predicate<br>device, it meets the requirement of essential performance standard ISO 10993 and<br>performance testing. The differences between the predicate device and subject device will not<br>affect the safety and effectiveness of the subject device | | | |

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# A Summary of the Non-clinical Testing Conducted:

The United Sewing High Fluid Resistant Disposable Face Mask and United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask has met the standards listed in the table below:

| Title of Performance Test<br>[Performance Aspect] | Test Method | Test Method<br>Acceptance Criteria | Results<br>Pass |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------|------------------------------------------------|
| Resistance of Medical Face Mask to<br>Penetration by Synthetic Blood<br>(Horizontal Projection of Fixed Volume<br>at a Known Velocity)<br>[Fluid Resistance] | ASTM F1862M-<br>17 | Fluid resistant claimed<br>at 160 mm Hg | 32/32 Passed<br>at 160 mmHg |
| Medical face masks - Requirements<br>and test methods<br>Standard Test Method for Evaluating<br>the Bacterial Filtration Efficiency (BFE)<br>of Medical Face Mask Materials, Using<br>a Biological Aerosol of Staphylococcus<br>aureus<br>[Bacterial Filtration Efficiency] | EN 14683:2019,<br>Annex C<br>ASTM F2101-<br>19*‡ | Pass ≥98% | 32/32 Passed<br>at 99.62% |
| Medical face masks - Requirements<br>and test methods<br>(Differential Pressure) - Delta P test<br>[Air Exchange] | EN 14683:2019,<br>Annex C<br>ASTM F2101-19* | Pass <6 mm H2O/cm | 32/32 passed<br>at 4.8 mm<br>H2O/cm² |
| Standard for the Flammability of<br>Clothing Textiles<br>[Flammability] | 16 CFR 1610‡ | Class 1 | 32/32 Passed<br>(≥3.5 seconds)<br>Class 1 Pass |
| Standard Test Method for Determining<br>the Initial Efficiency of Materials Used<br>in Medical Face Masks to Penetration<br>by Particulates Using Latex Spheres<br>[Particulate Filtration] | ASTM F2299 | ≥ 98% | 32/32 Passed<br>at 99.76% |

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- . 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.

3) Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

# A Summary of the Clinical Testing Conducted:

No clinical study is included in this submission

### Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(k) submission K202697. the United Sewing High Fluid Resistant Disposable Face Mask and United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are as safe, as effective, and perform as well as or better than the legally marketed predicate devices cleared under K191355.