Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) 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 with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) are single use, disposable device(s), provided non-sterile.

Device Description

The subject device(s) are ASTM Level 1 (blue in color) Surgical and Procedure Mask(s). The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are a three-layer mask, constructed of non-woven materials. The Surgical Masks (28802) are provided with ties while the Procedure Masks (25869) are provided with earloops. A malleable nosepiece is placed within the bindings to conform with the wearer's nose. The Fluidshield* 1 Procedure Mask and the Fluidshield* 1 Surgical Mask are single use, disposable devices, provided non-sterile.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (surgical masks), not for an AI/software device. Therefore, the information requested regarding acceptance criteria, study design, ground truth establishment, and expert involvement for a software/AI device is not applicable and cannot be extracted from this document.

The document describes the non-clinical performance testing for surgical masks, which focuses on physical and biological properties rather than AI algorithm performance.

Here's an analysis of the provided information, specifically addressing the non-AI device context:

1. A table of acceptance criteria and the reported device performance:

Test	Purpose	Acceptance Criteria	Reported Device Performance (28802 - Surgical Mask)	Reported Device Performance (25869 - Procedure Mask)
ASTM F2101 (Bacterial Filtration)	To demonstrate adequate bacterial filtration efficiency	Under study conditions, at least 95% efficiency	Pass	Pass
EN 14683:2019 +AC Annex C (Breathability)	To demonstrate acceptable breathability	Under study conditions, at most 5.0 mm H2O/cm²	Pass	Pass
ASTM F2299 (Particulate Filtration)	To demonstrate adequate particulate filtration efficiency	Under study conditions, at least 95% efficiency	Pass	Pass
ASTM F1862 (Resistance to Liquids)	To demonstrate adequate resistance to liquids	Under study conditions, passing at 80 mmHg conditions	Pass	Pass
16 CFR 1610 (Flame Spread Resistance)	To evaluate flame spread resistance	Class 1 under tested conditions	Pass	Pass
ASTM F2100-19 (Mask Performance)	To evaluate mask performance	Level 1 under evaluated conditions	Pass	Pass
ISO 10993-5 (Cytotoxic Potential)	To evaluate the cytotoxic potential of the mask	Under study conditions, non-cytotoxic	Pass	Pass
ISO 10993-10 Sensitization	To evaluate the sensitization potential of the mask	Under study conditions, not a sensitizer	Pass	Pass
ISO 10993-10 Irritation	To evaluate the irritation potential of the mask	Under study conditions, not an irritant	Pass	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the exact sample sizes used for each of these non-clinical performance tests. These are standard laboratory tests typically performed on a statistically relevant number of samples to ensure representativeness. The provenance (country of origin, retrospective/prospective) is not detailed for these laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable to the performance testing of surgical masks. Ground truth, in the context of material and product performance, is established by adherence to standardized testing protocols (e.g., ASTM, ISO, EN) and validated laboratory methods, not by expert consensus or interpretations of complex data like medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. These are objective, quantitative laboratory tests with defined pass/fail criteria, not subjective assessments requiring expert 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-assisted device.

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

Not applicable. This is not an AI-assisted device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for these tests is the objective measurement against established performance standards (e.g., specific filtration percentages, pressure differentials, flame spread classes), as defined by the international standards mentioned (ASTM, EN, ISO, CFR).

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI medical device like a surgical mask.

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

Not applicable. There is no training set for a non-AI medical 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.

June 21, 2024

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

Re: K232807

Trade/Device Name: Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 17, 2024 Received: May 17, 2024

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 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"

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(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 OS 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 G

For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K232807

Device Name

Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)

Indications for Use (Describe)

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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K232807 510(k) Summary

Date Summary wasPrepared	June 21, 2024
510(k) Submitter	O & M Halyard, Inc.1 Edison DriveAlpharetta, GA 30005
Primary Contact for this510(k) Submission	Angela L. Bunn, RACTel: 470-347-7147Email: angela.bunn@owens-minor.com
Marketed Common Name	Surgical Mask and Procedure Mask
Device Submission TradeName and Description	Fluidshield * 1 Procedure Mask with SO SOFT* Lining and SOSOFT* Earloops (25869);Fluidshield * 1 Surgical Mask with SO SOFT* Lining (28802)
Device Common Name	Surgical Mask and Procedure Mask
Device Product Code andClassification Name	FXX Class II, 21 CFR §878.4040 Surgical Apparel
Predicate Device	KC 100 Fluidshield* Surgical Masks and Procedure Masks(K110455)
Subject Device Description	The subject device(s) are ASTM Level 1 (blue in color) Surgicaland Procedure Mask(s). The Fluidshield* 1 Procedure Mask andthe Fluidshield* 1 Surgical Mask are a three-layer mask,constructed of non-woven materials. The Surgical Masks(28802) are provided with ties while the Procedure Masks(25869) are provided with earloops. A malleable nosepiece isplaced within the bindings to conform with the wearer's nose.The Fluidshield* 1 Procedure Mask and the Fluidshield* 1Surgical Mask are single use, disposable devices, providednonsterile.

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Indications for Use	Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SOSOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SOSOFT* Lining (28802) are intended to be worn to protect boththe patient and healthcare personnel from transfer ofmicroorganisms, body fluids, and particulate material. These facemasks are intended for use in infection control practices toreduce the potential exposure of the wearer to blood and bodyfluids. The Fluidshield* 1 Procedure Mask with SO SOFT* Liningand SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask withSO SOFT* Lining (28802) are single use, disposable device(s),provided non-sterile.
Technological Characteristics Comparison Table
	Subject Device	Predicate Device(K110455)KC 100 Surgical andProcedure Masks	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	Fluidshield * 1 ProcedureMask with SO SOFT* Liningand SO SOFT* Earloops(25869);Fluidshield * 1 SurgicalMask with SO SOFT* Lining(28802)	KC100 Surgical MaskKC100 Procedure Mask	Similar
Intended Use	Fluidshield* 1 ProcedureMask with SO SOFT* Liningand SO SOFT Earloops(25869); Fluidshield* 1Surgical Mask with SOSOFT* Lining (28802) areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure of the wearer toblood and body fluids.Fluidshield* 1 ProcedureMask with SO SOFT* Liningand SO SOFT Earloops(25869); Fluidshield* 1Surgical Mask with SOSOFT* Lining (28802) aresingle use, disposabledevice(s), provided non-	The Kimberly-Clark,KC100 Face Mask(s) areintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure ofthe wearer to blood andbody fluids. TheKimberly-Clark, KC100face mask(s) is a singleuse, disposable devices,provided non-sterile.	Same
	sterile.
Materials of Construction for Surgical Masks (28802)
Outer Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Media Filter	Meltblown polypropylene	Meltblownpolypropylene	Same
Inner Layer	Polyethylene polyester	Polyethylene polyester	Same
Bindings	Polyester polypropylene	Spunbondpolypropylene, Polyesterspunlace	Same
Ties (Surgical)	Spunbond polypropylene	Polyester spunlace	Different
Nose Wire	Aluminum	Aluminum	Same
Materials of Construction for Procedure Masks (25869)
Outer Layer	Spunbond polypropylene	Spunbond polypropylene	Same
Media Filter	Meltblown polypropylene	Meltblownpolypropylene	Same
Inner Layer	Polyethylene polyester	Polyethylene polyester	Same
Bindings	Polyester spunlace	Polyester spunlace	Same
Earloops (Procedure)	Polyester lycra	Polyester lycra	Same
Nose Wire	Aluminum	Aluminum	Same
Design Attributes for Surgical Masks (28802)
# of Layers	3-layer	3-layer	Same
Style	Pleated	Pleated	Same
Color	Blue	Blue	Same
Ties (Surgical)	Yes	Yes	Same
Nose Wire	Enclosed	Enclosed	Same
Design Attributes for Procedure Masks (25869)
# of Layers	3-layer	3-layer	Same
Style	Pleated	Pleated	Same
Color	Blue	Blue	Same
Earloops (Procedure)	Yes	Yes	Same
Performance Data/Product Claims for Surgical Masks (28802)
Fluid ResistanceLevel	ASTM F2100:19 Level 1	ASTM F2100 Level 1	Same
EN 14683	Type IIR	No	Different
Single Use Device	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Performance Data/Product Claims for Procedure Masks (25869)
Fluid ResistanceLevel	ASTM F2100:19 Level 1	ASTM F2100:07 Level 1	Similar
EN 14683	Type IIR	No	Different
Single Use Device	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same

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Summary of Performance Testing:

Test	Purpose	Criteria	Result
			28802	25869
ASTM F2101	To demonstrate adequatebacterial filtrationefficiency	Under the conditions of thestudy, at least 95% efficiency	Pass	Pass
EN 14683:2019 +ACAnnex C	To demonstrate acceptablebreathability	Under the conditions of thestudy, at most 5.0 mm H2O/cm2	Pass	Pass
ASTM F2299	To demonstrate adequateparticulate filtrationefficiency	Under the conditions of thestudy, at least 95% efficiency	Pass	Pass
ASTM F1862	To demonstrate adequateresistance to liquids	Under the conditions of thestudy, passing at 80 mmHgconditions	Pass	Pass
16 CFR 1610	To evaluate flame spreadresistance	Class 1 under the conditions ofthe testing	Pass	Pass
ASTMF2100-19	To evaluate maskperformance	Level 1 under the conditions ofthe evaluation	Pass	Pass
ISO 10993-5	To evaluate the cytotoxicpotential of the mask	Under the conditions of thestudy, non-cytotoxic	Pass	Pass
ISO 10993-10Sensitization	To evaluate thesensitization potential ofthe mask	Under the conditions of thestudy, not a sensitizer	Pass	Pass
ISO 10993-10Irritation	To evaluate the irritationpotential of the mask	Under the conditions of thestudy, not an irritant	Pass	Pass

Summary of Clinical Testing

No clinical testing was performed in support of this submission.

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Fluidshield * 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops (25869); Fluidshield * 1 Surgical Mask with SO SOFT* Lining (28802) are as safe, as effective and perform as well as or better than the legally marketed predicate device 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.