The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-sterile.

Device Description

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose. The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non-sterile.

AI/ML Overview

This document describes the FDA 510(k) clearance for several Fluidshield® 3 Surgical and Procedure Masks. However, it does not contain the level of detail regarding study design, sample sizes, ground truth establishment, or expert qualifications that would be present in a comprehensive study report for an AI/software device. The information provided is typical for a medical device clearance describing performance characteristics and compliance with standards, not for an AI comparative effectiveness or standalone study.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria	Reported Device Performance
Face Mask Performance	ASTM F2100 Level 3	Pass (28800, 28804, 47137, 48207) - Implies all models meet Level 3
Bacterial Filtration Efficiency	≥98%	Pass
Particulate Filtration Efficiency	≥98%	Pass
Differential Pressure	<6.0 mmH₂O/cm²	Pass
Fluid Resistance	160 mmHg	Pass
Flammability	Class 1	Pass
Biocompatibility	(Not specified in table)	Pass (28800, 28804, 47107, 48207) - Implies all models meet standard
Cytotoxicity	Non-cytotoxic	Pass
Sensitization	Non-sensitizing	Pass
Irritation	Non-irritant	Pass

Study Details (Based on available information in the document)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The document lists "Pass" for various tests, but does not detail the number of masks or samples tested for each criterion.
- Data Provenance: Not specified. The tests are non-clinical (laboratory-based) tests of the physical properties and performance of the mask materials and construction. They are not based on patient data, but rather on material testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/software device study involving expert interpretation of data. The "ground truth" here refers to the quantitative results of standardized non-clinical material performance tests, performed by laboratory personnel according to the specified ASTM and ISO standards.
Adjudication method for the test set:
- Not applicable. The performance is measured against objective, standardized physical testing methods rather than subjective expert consensus requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document is for the premarket notification (510(k)) of physical medical devices (surgical masks), not an AI/software as a medical device (SaMD). Therefore, no MRMC study or AI performance evaluation was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
The type of ground truth used:
- The "ground truth" for the performance claims of these masks is based on standardized non-clinical laboratory testing results as defined by the ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards listed (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These are objective, measurable physical properties and biocompatibility assessments.
The sample size for the training set:
- Not applicable. This is not an AI/software device and therefore does not involve training sets.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary of the Study:

The "study" referenced in this document is a series of non-clinical laboratory tests to demonstrate that the Fluidshield® 3 Surgical and Procedure Masks meet established performance standards for medical face masks, specifically ASTM F2100 Level 3. These tests evaluate properties such as bacterial filtration efficiency, particulate filtration efficiency, differential pressure (breathability), fluid resistance, flammability, and biocompatibility (cytotoxicity, sensitization, irritation).

The conclusion states that the nonclinical tests demonstrate the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, forming the basis for its 510(k) clearance for market.

Summary

FDA 510(k) Clearance Letter - K243010

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 30, 2025

Owens & Minor (O&M) Halyard, Inc.
Angela Bunn
Sr. Director, Global Regulatory
9120 Lockwood Blvd
Mechanicsville, Virginia 23116

Re: K243010

Trade/Device Name: Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor (28800); Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (47107); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor (47137); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor (47147)

Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FXX
Dated: September 26, 2024
Received: April 25, 2025

Dear Angela Bunn:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

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K243010 - Angela Bunn Page 2

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

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K243010 - Angela Bunn Page 3

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243010

Device Name:
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor (28800); Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (47107); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor (47137); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor (47147)

Indications for Use (Describe):
The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s) and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non-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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary – K243010

Date Summary was Prepared	May 29, 2025
510(k) Submitter	O & M Halyard, Inc.1220 Old Alpharetta Rd, Suite 320Alpharetta, Georgia 30005
Primary Contact for this 510(k) Submission	Angela L. Bunn, RACTel: 470‐347‐7147Email: angela.bunn@owens‐minor.com
Marketed Common Name	Surgical Mask and Procedure Mask
Device Submission Trade Name	Surgical MasksFluidshield * 3 Fog‐Free Surgical Mask with Wraparound Anti‐Glare Visor (28804)Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208)Fluidshield * 3 Fog‐Free Surgical Mask with SO SOFT* Lining (48207)Fluidshield * 3 Fog‐Free Surgical Mask with SO SOFT* Lining, with Visor (48237)Fluidshield* 3 Fog‐Free Surgical Mask with SO SOFT* Lining, Anti‐Glare WrapAround Visor (48247)Procedure MasksFluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Earloops (28797)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor (28800)Fluidshield* 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (47107)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor (47137)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor (47147)
Device Common Name	Surgical Mask and Procedure Mask
Device Product Code and Classification Name	FXX Class II, 21 CFR §878.4040 Surgical Apparel
Predicate Device	KC 200 Fluidshield* Surgical Masks and Procedure Masks and KC 300 Fluidshield* Surgical Masks and Procedure Masks (K111402)

Page 1 of 6

Page 6

Subject Device Description	The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four‐layer mask, constructed of well‐known non‐woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose.The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non‐sterile.
Indications for Use	The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s)and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non‐sterile.

Subject Device Description

The subject device(s) are ASTM F2100 Level 3 (orange in color) Surgical and Procedure Mask(s). The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Masks family of products are a four‐layer mask, constructed of well‐known non‐woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Masks are provided with earloops. A malleable nosepiece is placed within the bindings to conform around the wearer's nose.The Fluidshield* 3 Surgical Mask(s)s and Fluidshield* 3 Procedure Mask(s) family will be provided in designs with and without a protective visor. The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) family are single use, disposable devices, provided non‐sterile.

Indications for Use

The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Masks(s)and Fluidshield* 3 Procedure Face Mask(s) are single use, disposable device(s), provided non‐sterile.

Device Comparison Table

	Subject Devices K243010	Predicate Device K111402	Comparison
FDA Product Code	FXX	FXX	Same
FDA Classification	Class II	Class II	Same
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Common Name	Surgical Mask	Surgical Mask	Same
Device Trade Name	Surgical MasksFluidshield * 3 Fog‐Free Surgical Mask with Wraparound Anti‐Glare Visor (28804)Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208)Fluidshield * 3 Fog‐Free Surgical Mask with SO SOFT* Lining (48207)	KC200 Procedure MaskKC200 Procedure Mask, fog‐free with visorKC200 Surgical Mask, fog‐freeKC200 Surgical Mask, fog‐free with visorKC300 Procedure Mask, Fluidshield, fog‐freeKC300 Procedure Mask, Fluidshield, fog‐free with visor	SimilarThere are differing inner lining materials and differing options than cleared previously.

Page 2 of 6

Page 7

Device Trade Name (continued)	Fluidshield * 3 Fog‐Free Surgical Mask with SO SOFT* Lining, with Visor (48237)Fluidshield* 3 Fog‐Free Surgical Mask with SO SOFT* Lining, Anti‐Glare WrapAround Visor (48247)Procedure MasksFluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Earloops (28797)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor(28800)Fluidshield* 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (47107)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor (47137)Fluidshield * 3 Fog‐Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor (47147)	KC300 Surgical Mask, Fluidshield, fog‐freeKC300 Surgical Mask, Fluidshield, fog‐free with visor

Page 3 of 6

Page 8

	Subject Devices K243010	Predicate Device K111402	Comparison
Intended Use	The Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) 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 the potential exposure of the wearer to blood and body fluids. Fluidshield* 3 Surgical Mask(s) and Fluidshield* 3 Procedure Mask(s) are single use, disposable device(s), provided non‐sterile.	The Kimberly‐Clark, KC200 and KC300 Face Mask(s) 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 the potential exposure of the wearer to blood and body fluids. The Kimberly‐Clark, KC200 and KC300 face mask(s) is a single use, disposable device(s), provided non‐sterile.	SameThis submission does not cover the KC 200 Blue Surgical or Procedure Masks.

Materials of Construction for Surgical Mask Family

Component	Subject Device	Predicate Device	Comparison
Outer Layer	Spunbond polypropylene (or) Polyester Cellulose	Spunbond polypropylene	Similar ‐ Additional material was tested and is safe and effective.
2nd Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Media Filter	Meltblown polypropylene	Meltblown polypropylene	Same
Inner Layer	Polyethylene Polyester(or) Polyester Cellulose	Polyester Cellulose	Different ‐ Additional material was tested and is safe and effective.
Bindings	Spunbond polypropylene, Polyester spunlace	Spunbond polypropylene, Polyester spunlace	Same
Ties (Surgical)	Spunbond polypropylene	Spunbond polypropylene	Same
Foam	Polyester/Polyester Spunlace	Polyester	Same
Visor(certain designs)	Polyester Film	Polyester Film	Same
Nose Wire	Aluminum	Aluminum	Same

Materials of Construction for Procedure Mask Family

Component	Subject Device	Predicate Device	Comparison
Outer Layer	Spunbond polypropylene	Spunbond polypropylene	Same
2nd Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Media Filter	Meltblown polypropylene	Meltblown polypropylene	Same
Inner Layer	Polyethylene Polyester(or) Polyester Cellulose	Polyester Cellulose	Different ‐ Additional material was tested and is safe and effective.
Bindings	Polyester spunlace	Polyester spunlace	Same

Page 4 of 6

Page 9

Component	Subject Device	Predicate Device	Comparison
Earloops (Procedure)	Polyester/lycra	Polyester/lycra	Same
Foam	Polyester foam/polyester spunlace laminate	Polyester foam/polyester spunlace laminate	Same
Visor(some designs)	Polyester Film	Polyester Film	Same
Nose Wire	Aluminum	Aluminum	Same

Design Attributes for Surgical Masks

Attribute	Subject Device	Predicate Device	Comparison
# of Layers	4‐layer	4‐layer	Same
Color	Orange	Orange	Same
Ties (Surgical)	Yes	Yes	Same
Visor	Some Designs	Some Designs	Same
Nose Wire	Enclosed	Enclosed	Same

Design Attributes for Procedure Masks

Attribute	Subject Device	Predicate Device	Comparison
# of Layers	4‐layer	4‐layer	Same
Color	Orange	Orange	Same
Earloops (Procedure)	Yes	Yes	Same
Visor	Some Designs	Some Designs	Same

Performance Data/Product Claims

Attribute	Subject Device	Predicate Device	Comparison
Fluid Resistance	3	3	Same
EN 14683	Yes	No	Different
Single Use Device	Yes	Yes	Same
Sterility	Non‐Sterile	Non‐Sterile	Same

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Page 10

Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device(s) met all design specifications as was same/similar to the predicate device(s). The test results demonstrated that the proposed device complies with the following standards:

Purpose	Test	Acceptance Criteria	Result
Face Mask Performance	ASTM F2100	ASTM F2100 Level 3	Pass (28800, 28804, 47137, 48207)
Bacterial Filtration Efficiency	ASTM F2101	≥98%	Pass
Particulate Filtration Efficiency	ASTM F2299	≥98%	Pass
Differential Pressure	EN 14683	<6.0 mmH2O/cm²	Pass
Fluid Resistance	ASTM F1862	160 mmHg	Pass
Flammability	16 CFR Part 1610	Class 1	Pass
Biocompatibility	ISO 10993		Pass (28800, 28804, 47107, 48207)
Cytotoxicity	ISO 10993‐5	Non‐cytotoxic	Pass
Sensitization	ISO 10993‐10	Non‐sensitizing	Pass
Irritation	ISO 10993‐10	Non‐irritant	Pass

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.

Page 6 of 6

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.