The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

Device Description

The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user’s nose.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (ASTM F2100-19 Level 3)	Reported Device Performance (K201844)	Predicate Device Performance (K201479)
Fluid Resistance (ASTM F1862)	160 mmHg	Pass	Pass
Particulate Filtration Efficiency (ASTM F2299, 0.1 micron)	≥ 98%	Avg. 99.0%	≥ 99%
Bacterial Filtration Efficiency (ASTM F2101)	≥ 98%	Avg. 99.1%	≥ 99%
Differential Pressure (EN 14683:2019, Annex C)	< 5.0 mmH2O/cm^2	Avg. 4.9 mmH2O/cm^2	Avg. 3.6 mmH2O/cm^2 (MIL-M36954C)
Flammability (16 CFR Part 1610)	Class 1	Class 1	Class 1
Biocompatibility (ISO 10993-5, ISO 10993-10)	Pass (Cytotoxicity, Irritation, Sensitization)	Pass	Pass

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "the proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993." These standards typically specify the number of samples required for each test.

The data provenance is from nonclinical testing performed on the "proposed Surgical Face Mask" (K201844). No information is provided regarding the country of origin of the data or if it was retrospective or prospective, though nonclinical performance testing is generally prospective in nature.

3. Number of Experts and Qualifications

This submission pertains to the performance testing of a physical medical device (surgical face mask) against established industry standards (ASTM, ISO). Expert interpretation of images or other subjective data is not relevant here. The ground truth for these tests is based on objective, quantifiable measurements performed according to standardized protocols.

4. Adjudication Method

Not applicable. The tests are objective measurements against defined criteria. There is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a submission for a physical device, not an AI software or system that requires human-in-the-loop performance evaluation.

6. Standalone Performance Study

Yes, a standalone study was done. The entire summary outlines the results of the performance testing of the proposed Surgical Face Mask (K201844) without any human interaction beyond setting up and executing the standardized tests.

7. Type of Ground Truth Used

The ground truth for this study is based on objective measurements obtained through standardized testing protocols. Each test (e.g., fluid resistance, BFE, PFE, differential pressure, flammability, biocompatibility) has specific, quantifiable metrics that define "pass" or "fail" according to the relevant ASTM, EN, and ISO standards.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product whose performance is evaluated through laboratory testing.

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

Not applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth established for a training set.

Summary

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July 14, 2021

Lear Corporation Ryan Facer Product Development Engineer 1 Penn Dve St Pine Grove, Pennsylvania 17963

Re: K201844

Trade/Device Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 15, 2021 Received: June 16, 2021

Dear Ryan Facer:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K201844

Device Name

Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask

Indications for Use (Describe)

The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healtheare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

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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5. 510(k) Summary Report

K201844

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared: 06/10/2021

5.1. Submitter's Identification

Guilford Performance Textiles by Lear 1 Penn Dye St Pine Grove, PA 17963 USA

Contact Person: Ryan Facer Telephone: (336) 341-8687 Email: rfacer@lear.com

5.2. Device & Regulatory Information

Trade Name: Disposable Surgical Face Mask, Surgical Face Mask, Surgical Mask Model Number: 69005 Common Name: Surgical Mask 510(k) Number: K201844 Classification Name: Mask, Surgical Classification: Class II Product Code: FXX Regulation Number: 21 CFR 878.4040

5.3. Predicate Device

Submitter: DemeTECH Corporation 510(k) Number: K201479 Device Name: DemeMASK Surgical Mask

5.4. Device Description:

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The types of materials used in the proposed Surgical Face Mask are currently being used in legally marketed devices.

5.5. Contact

Type: Surface Device – Intact Skin Contact Duration: Limited – Less than 24 hours

5.6. Intended Use

5.7. Comparison to Predicate Device

5.7.1. Intended Use/Indications for Use

Proposed Surgical Face Mask(K201844)	Predicate Surgical Mask(K201479)	Comparison
The Surgical Face Mask is intendedfor single use by operating roompersonnel, patients, and othergeneral healthcare workers toprotect against the transfer ofmicroorganisms, blood, bodily fluids,and particulates. This is a non-sterile, single use, disposable device.	The Disposable Surgical Face Masksare intended to be worn to protectboth the patient andhealthcare personnel from transferof microorganisms, body fluids andparticulate material. Theseface masks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable deviceprovided non-sterile.	Intended use/Indications for Use isthe same as thepredicate device

5.7.2. Materials, Technical Specifications, & Risks to Health

Description	Proposed SurgicalFace Mask(K201844)	Predicate SurgicalMask(K201479)	Comparison
Materials	Inner Layer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same as thepredicate device
	Middle Layer	Melt blownpolypropylene	Melt blownpolypropylene	Same as thepredicate device
	Outer Layer	Spun-bondpolypropylene	Spun-bondpolypropylene	Same as thepredicate device
	Nose Wire	Galvanized steel wirecoated withpolypropylene	Galvanized wirecoated withpolyethylene	Similar to thepredicate device

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	Elastic ear-loops	Nylon & spandex	Nylon & spandex	Same as thepredicate device
	Mask Style	Flat Pleated	Flat pleated	Same as thepredicate device
Specifications	Design Feature	Ear loops(Length: 150 mm)	Ear loops(Length: not provided)	Similar topredicate device
	Nose Wire	Length: 110 mm	Info not provided	Similar topredicate device
	Mask Dimensions	Length - 6.89 inWidth – 3.74 in	Length - 6.89 inWidth — 3.74 in	Same as thepredicate device
Performancetestresults	Fluid ResistanceASTM 1862(160 mmHg)	Pass	Pass	Same as thepredicate device
	ParticulateFiltrationEfficiencyASTM F2299(0.1 micron)	Avg. 99.0%	≥99%	Similar to thepredicate device
	Bacterial FiltrationEfficiencyASTM F2101	Avg. 99.1%	≥99%	Similar to thepredicate device
	DifferentialPressureASTM F2100-19	Avg. $4.9 mmH_2O/cm^2$	* Avg. $3.6 mmH_2O/cm^2$	Similar topredicate device
	Flammability16 CFR Part 1610	Class 1	Class 1	Same as thepredicate device
	BiocompatibilityISO 10993-5 & ISO10993-10(Cytotoxicity,Irritation,Sensitization)	Pass	Pass	Same as thepredicate device

*Predicate device was tested per MIL-M36954C.

5.8. Summary of Nonclinical Testing

The proposed Surgical Face Masks have been tested according to ASTM F2100-19, the relevant standards which comprise ASTM F2100-19, and ISO 10993 in order to determine substantial equivalence. The following tests were conducted on the proposed Surgical Face Masks:

ASTM F1862 Test Method for Resistance of Medical Face Masks to Penetration l. by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

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II. ASTM F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
III. ASTM F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
IV. EN 14683:2019, Annex C Method for Determination of Breathability (Differential Pressure)
V. 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
VI. ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
VII. ISO 10993-10 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization

All results of testing met ASTM F2100-19 level 3 acceptance criteria.

5.9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201844, the Surgical Face Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201479.

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.