The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical 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 FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) are single use, disposable device(s), provided non-sterile.

Device Description

The subject device(s) are ASTM F2100 Level 1 (white in color) Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Surgical Masks are provided with ties while the Procedure Mask(s) are provided with earloops. A malleable nosepiece is placed within the bindings. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family will be provided in designs with and without a protective visor. The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are single use, disposable devices, provided non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Purpose	Test	Acceptance Criteria	Reported Device Performance (Result)
Face Mask Performance	ASTM F2100	ASTM F2100 Level 1	Pass
Bacterial Filtration Efficiency	ASTM F2101	≥95%	Pass
Particulate Filtration Efficiency	ASTM F2299	≥95%	Pass
Differential Pressure	EN 14683	<5.0 mmH₂O/cm²	Pass
Fluid Resistance	ASTM F1862	80 mmHg	Pass
Flammability	16 CFR Part 1610	Class 1	Pass
Biocompatibility	ISO 10993		Pass
Cytotoxicity	ISO 10993-5	Non-cytotoxic	Pass
Sensitization	ISO 10993-10	Non-sensitizing	Pass
Irritation	ISO 10993-10	Non-irritant	Pass

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing. For these types of tests, specific "test sets" of data provenance like country of origin or retrospective/prospective often don't apply in the same way they would for clinical studies. The tests are typically performed on samples of the manufactured device. The document does not specify the exact number of samples used for each test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for these performance tests is established by standardized testing protocols and measurement methodologies, not expert consensus. These are objective measurements of material properties.

4. Adjudication method for the test set:

Not applicable. The tests involve objective measurements against predefined acceptance criteria, not subjective interpretation requiring adjudication.

5. 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 is not an AI-powered device or a diagnostic device that would involve human readers. The device is a surgical mask.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

The ground truth used for these tests is based on standardized test methods and calibrated equipment. For example:

Bacterial Filtration Efficiency (BFE): Measured using ASTM F2101, which involves generating a biological aerosol and quantifying bacterial penetration. The "ground truth" is the scientific measurement of the filtration efficiency.
Fluid Resistance: Measured using ASTM F1862, which involves propelling synthetic blood at a known pressure. The "ground truth" is the measured penetration.
Biocompatibility (Cytotoxicity, Sensitization, Irritation): Evaluated against recognized biological safety standards (ISO 10993) where "non-cytotoxic," "non-sensitizing," and "non-irritant" are the ground truths determined by the specific test methodologies.

8. The sample size for the training set:

Not applicable. This device is a physical medical device (surgical mask) and does not involve AI or machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 2, 2024

Owens & Minor (O&M) Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116

Re: K232824

Trade/Device Name: FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 31, 2024

Dear Caitlin Senter:

Received: May 31, 2024

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 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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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 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-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 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.

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 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,

Allan Guan -S

For Bifeng Qian, M.D., Ph.D. Assistant Director

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DHT4B: Division of Infection Control and Plastic and Reconstructive 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) K232824

Device Name

Indications for Use (Describe)

FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803)

FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)

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/4/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, and it features the letters "OM" in a bold, red font, with the words "Owens & Minor" in a smaller, gray font to the right. The second logo is for Halyard, and it features a blue circle with a white and green design inside, followed by the word "HALYARD" in a bold, blue font.

510(k) Summary (K232824)

Date Summarywas Prepared	June 28, 2024
510(k) Submitter	O & M Halyard, Inc.9120 Lockwood BoulevardMechanicsville, VA 231161
Primary Contact forthis 510(k) Submission	Caitlin Senter, MS, RACTel: 678-221-7330Email: caitlin.senter@owens-minor.com
Marketed Common Name	Procedure Mask and Surgical Mask
Device Submission TradeName and Description	Procedure MaskFLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Liningand SO SOFT* Earloops, White (41802)FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Liningand SO SOFT* Earloops, White, Wrap Around Visor (41803)Surgical MaskFLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White,(41805)
Device Common Name	Procedure Mask and Surgical Mask
Device Product Codeand Classification Name	FXX Class II, 21 CFR §878.4040 Surgical Apparel
Predicate Device	Kimberly-Clark KC100 Face Masks (K110455)
Subject DeviceDescription	The subject device(s) are ASTM F2100 Level 1 (white in color)Procedure and Surgical Mask(s). The FLUIDSHIELD* 1 ProcedureMask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family of productsare a three-layer mask, constructed of well-known non-wovenmaterials used in facial protection. The Surgical Masks areprovided with ties while the Procedure Mask(s) are provided withearloops. A malleable nosepiece is placed within the bindings.The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1Surgical Mask(s) family will be provided in designs with andwithout a protective visor. The FLUIDSHIELD* 1 ProcedureMask(s) and FLUIDSHIELD* 1 Surgical Mask(s) family are singleuse, disposable devices, provided non-sterile.
Indications for Use	The FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1Surgical Mask(s) are intended to be worn to protect both thepatient 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 FLUIDSHIELD* 1 Procedure Mask(s) and FLUIDSHIELD* 1
Surgical Mask(s) are single use, disposable device(s), provided
non-sterile.

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Image /page/5/Picture/0 description: The image contains two company logos. The first logo is for Owens & Minor, which features the letters "OM" in a bold, maroon color, with the words "Owens & Minor" in a smaller, gray font to the right. The second logo is for Halyard, which features a green and blue symbol resembling a stylized mountain or upward-pointing arrow, followed by the word "HALYARD" in a bold, dark blue font.

Technological Characteristics Comparison Table
	Subject Device	Predicate Device(K110455)Kimberly-Clark KC100Face Masks	Comparison
FDA Product Code	FLUIDSHIELD* 1 ProcedureMask(s) and FLUIDSHIELD*1 Surgical Mask(s)
	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	Procedure Mask(s)		Similar
	FLUIDSHIELD* 1 Fog-FreeProcedure Mask with SOSOFT* Lining and SO SOFT*Earloops, White (41802)	KC100 Procedure Mask,Lavender, Blue, Yellow,Green, White
	FLUIDSHIELD* 1 Fog-FreeProcedure Mask with SOSOFT* Lining and SO SOFT*Earloops, White, WrapAround Visor (41803)	KC100 Procedure Maskwith visor, Lavender, Blue,Yellow, Green, White	The predicatedevice wascleared with amultitude ofcolors whilethe subjectdevice isoffered inwhite only.
	Surgical Mask(s)	KC100 Procedure Maskwith fog-free strip,Lavender, Blue, Yellow,Green, White
	FLUIDSHIELD* 1 SurgicalMask with SO SOFT* Lining,White, (41805)
Intended Use	The FLUIDSHIELD* 1Procedure Mask(s) andFLUIDSHIELD* 1 SurgicalMask(s) are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use in	The Kimberly-Clark KC100Face Mask(s) is intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce the	Same

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Image /page/6/Picture/0 description: The image shows two company logos side by side. On the left is the Owens & Minor logo, featuring a stylized maroon "OM" symbol with horizontal lines, followed by the company name in gray text. To the right is the Halyard logo, which includes a green and white upward-pointing arrow within a dark blue circle, accompanied by the company name in bold, dark blue letters.

	infection control practicesto reduce the potentialexposure of the wearer toblood and body fluids. TheFLUIDSHIELD* 1 ProcedureMask(s) and FLUIDSHIELD*1 Surgical Mask(s) are singleuse, disposable device(s),provided non-sterile.	potential exposure of thewearer to blood and bodyfluids. The Kimberly-ClarkKC100 face mask(s) is asingle use, disposabledevice(s), provided non-sterile.
Design Attributes
# of Layers	3-layer	3-layer	Same
Color	White	White	Same
Earloops (Procedure)	Yes	Yes	Same
Ties (Surgical)	Yes	Yes	Same
Visor	Some Designs	Some Designs	Same
Performance Data/Product Claims
Fluid Resistance Level	1	1	Same
Single Use Device	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same

Summary of Non-Clinical Performance Testing:

Non-clinical tests were conducted to verify that the proposed device(s) met all design specifications similar to the predicate device(s).

	Table:

Purpose	Test	Acceptance Criteria	Result
Face Mask Performance	ASTM F2100	ASTM F2100 Level 1	Pass
Bacterial Filtration Efficiency	ASTM F2101	≥95%	Pass
Particulate Filtration Efficiency	ASTM F2299	≥95%	Pass
Differential Pressure	EN 14683	<5.0 mmH2O/cm²	Pass
Fluid Resistance	ASTM F1862	80 mmHg	Pass
Flammability	16 CFR Part 1610	Class 1	Pass
Biocompatibility	ISO 10993		Pass
Cytotoxicity	ISO 10993-5	Non-cytotoxic	Pass
Sensitization	ISO 10993-10	Non-sensitizing	Pass
Irritation	ISO 10993-10	Non-irritant	Pass

The test results demonstrated that the proposed device complies with the following standards:

ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

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Image /page/7/Picture/0 description: The image shows the logos of two companies, Owens & Minor and Halyard Health. The Owens & Minor logo is on the left and features the company's initials in a bold, red font, with the full name in a smaller, gray font to the right. The Halyard Health logo is on the right and features a stylized green and blue symbol next to the company's name in a bold, blue font.

ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
A ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization

Summary of Clinical Performance Testing:

N/A

Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803), and FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) are as safe, as effective, and perform as well as or better than the legally marketed KC100 Face Masks (K110455).

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.