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 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.

AI/ML Overview

The FDA 510(k) summary for K202697 provides detailed acceptance criteria and the results of non-clinical studies for the United Sewing High Fluid Resistant Disposable Face Mask, Surgical Mask, and Procedure Mask.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Aspect	Test Method	Acceptance Criteria	Reported Device Performance
Fluid Resistance	ASTM F1862M-17	Fluid resistant claimed at 160 mmHg	32/32 Passed at 160 mmHg
Bacterial Filtration Efficiency (BFE)	EN 14683:2019, Annex C; ASTM F2101-19	Pass ≥98%	32/32 Passed at 99.62%
Differential Pressure (Air Exchange)	EN 14683:2019, Annex C; ASTM F2101-19	Pass <6 mm H2O/cm²	32/32 Passed at 4.8 mm H2O/cm²
Flammability	16 CFR 1610	Class 1	32/32 Passed (≥3.5 seconds) Class 1 Pass
Particulate Filtration Efficiency (PFE)	ASTM F2299	≥ 98%	32/32 Passed at 99.76%
Biocompatibility (Cytotoxicity)	ISO 10993-5:2009	Non-cytotoxic	Passed
Biocompatibility (Sensitization)	ISO 10993-10:2010	Non-sensitizing	Passed
Biocompatibility (Irritation)	ISO 10993-10:2010	Non-irritating	Passed

2. Sample Size Used for the Test Set and Data Provenance

For all performance tests (Fluid Resistance, BFE, Differential Pressure, Flammability, PFE):

Sample Size: 32 samples were used for each test.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. These are non-clinical laboratory tests, so the concepts of retrospective/prospective clinical data do not directly apply.

For Biocompatibility testing:

The document implies that the tests were conducted using relevant samples of the device materials, but a specific sample size (e.g., number of test specimens or animals) for these tests is not explicitly stated.
Data Provenance: Not specified, but these are also non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This documentation describes non-clinical performance testing of a medical mask. The "ground truth" for such tests is typically established by recognized international and national standards (e.g., ASTM, EN, ISO, CFR) and the execution of these tests by accredited laboratories.
It does not involve human expert consensus for a "test set" in the way a clinical study or AI model validation would. The results are compared against predefined numerical acceptance criteria within the standards.

4. Adjudication Method for the Test Set

Not applicable as this is non-clinical performance testing against established standards, not a diagnostic or classification task requiring expert adjudication of results. The results are quantitative measurements compared directly to numerical pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device described is a physical medical face mask, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to report.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on established national and international standards and analytical test methods (e.g., ASTM F1862M-17, EN 14683:2019, ASTM F2101-19, 16 CFR 1610, ASTM F2299, ISO 10993 series). The device's physical properties and performance characteristics are measured and compared against the specific pass/fail criteria defined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI/ML context.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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.1772 N. Andy Griffith ParkwayMount Airy, NC 27030
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Contact information: Benjamin Web Title: CEO Phone: (336) 710-2404 Email: ben@unitedsewinginc.com
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:

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(K202697)United Sewing HighFluid ResistantDisposable Face Mask,also marketed undertrade names UnitedSewing High FluidResistant Surgical FaceMask and UnitedSewing High FluidResistant ProcedureFace Mask	Predicate Device(K160269)San-M Package Co.,Ltd. Surgical FaceMasks (Ear loops andTie-on)	Comparison
IntendedUse/Indicationsfor Use	The United Sewing HighFluid ResistantDisposable Face Mask,also marketed undertrade names UnitedSewing High FluidResistant Surgical FaceMask and United Sewing	The surgical facemasks are intended tobe worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulate	Similar
	High Fluid ResistantProcedure Face Mask, isintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. This face maskis intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This facemask is a single-use,disposable devices,provided non-sterile.	material. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single-use,disposable device,provided non-sterile.
Outer Layer	Polypropylene,Spunbound, 99.5%	Polypropylene	Same
Filter (Middle)Layer	Polypropylene, MeltBlown	PolypropyleneSpunbond;Polypropylenemeltblown	Same
Inner FacingLayer	Polypropylene,Spunbound, 99.5%	Polypropylene thermal-bonded	Same
Nose Piece	Polyethylene CoatedSingle Wire, 10.16 cm	Polyethylene coatedsteel wire	Same
Ear Loops	Nylon and Spandex, 12.7cm 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 mm92 mm ± 3 mm	Similar
Width	17.5 ± 0.5 cm	175 mm ± 5 mm180 mm ± 5mm	Similar
ParticulateFiltrationEfficiency (PFE)	99.76%ASTM F2299	PassASTM F2299	Similar
Fluid Resistance	Pass at 160 mm HgASTM F1862	Pass at 80-160 mm HgASTM F1862	Same
Bacterial FiltrationEfficiency (BFE)	99.62%ASTM F2101	Pass at ≥98%	Same
		ASTM F2101
DifferentialPressure	4.8 mm H2O/cm²EN 14683:2019 andASTM F2101-19	Pass at ≤2.5 H2O/cm²MIL-M36945C	Same
Flammability	Class 1, 16 CFR 1610	Class 1, 16 CFR 1610	Same
Biocompatibility	Non-cytotoxic, non-irritating, and non-sensitizing	Non-cytotoxic, non-sensitizing, non-irritating	Same
*Although the ear loop materials and color subject device are little difference with predicatedevice, it meets the requirement of essential performance standard ISO 10993 andperformance testing. The differences between the predicate device and subject device will notaffect 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[Performance Aspect]	Test Method	Test MethodAcceptance Criteria	ResultsPass
Resistance of Medical Face Mask toPenetration by Synthetic Blood(Horizontal Projection of Fixed Volumeat a Known Velocity)[Fluid Resistance]	ASTM F1862M-17	Fluid resistant claimedat 160 mm Hg	32/32 Passedat 160 mmHg
Medical face masks - Requirementsand test methodsStandard Test Method for Evaluatingthe Bacterial Filtration Efficiency (BFE)of Medical Face Mask Materials, Usinga Biological Aerosol of Staphylococcusaureus[Bacterial Filtration Efficiency]	EN 14683:2019,Annex CASTM F2101-19*‡	Pass ≥98%	32/32 Passedat 99.62%
Medical face masks - Requirementsand test methods(Differential Pressure) - Delta P test[Air Exchange]	EN 14683:2019,Annex CASTM F2101-19*	Pass <6 mm H2O/cm	32/32 passedat 4.8 mmH2O/cm²
Standard for the Flammability ofClothing Textiles[Flammability]	16 CFR 1610‡	Class 1	32/32 Passed(≥3.5 seconds)Class 1 Pass
Standard Test Method for Determiningthe Initial Efficiency of Materials Usedin Medical Face Masks to Penetrationby Particulates Using Latex Spheres[Particulate Filtration]	ASTM F2299	≥ 98%	32/32 Passedat 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:

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.
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.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.