HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
Device Facts
| Record ID | K251967 |
|---|---|
| Device Name | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor |
| Applicant | O&M Halyard, Inc. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Intended Use
The HALYARD* FLUIDSHIELD* 3 Fog-Free 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. These are single use, disposable device(s), provided nonsterile.
Device Story
Four-layer, flat-pleated, single-use, disposable surgical procedure mask; available with or without wraparound visor. Constructed from non-woven polypropylene and polyester materials; features malleable aluminum nosepiece and polyester/lycra earloops. Used in clinical settings for infection control; worn by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Device acts as a physical barrier; performance validated to ASTM F2100 Level 3 standards. Benefits include reduced risk of cross-contamination and fluid exposure during medical procedures.
Clinical Evidence
No clinical data. Bench testing only. Performance validated against ASTM F2100 Level 3, ASTM F2101 (BFE ≥98%), ASTM F2299 (PFE ≥98%), EN 14683 (Differential Pressure <6.0 mm H2O/cm2), ASTM F1862 (Fluid Resistance 160 mmHg), and 16 CFR Part 1610 (Flammability Class 1). Biocompatibility confirmed via ISO 10993 testing (systemic toxicity, sensitization, irritation, and cytotoxicity).
Technological Characteristics
Four-layer non-woven construction; outer/second layers: polypropylene spunbond; third layer: polypropylene meltblown; inner layer: PET/polyethylene BICO. Malleable aluminum nosepiece; polyester/lycra earloops; ultrasonic bonding. Non-sterile, single-use. ASTM F2100 Level 3 compliant. Biocompatibility per ISO 10993.
Indications for Use
Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- KC300 Procedure Face Masks (K111402)
Related Devices
- K203064 — ICU Health Surgical Mask · Plastikon Industries · Mar 23, 2021
- K223232 — Procedure mask/Surgical mask/Face mask · Winner Medical Co., Ltd. · Mar 6, 2023
- K212109 — Spin Care Disposable Protective Mask Level 3 · Spintech, LLC · Nov 14, 2021
- K243010 — 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 Proce · Owens & Minor (O&M) Halyard, Inc. · May 30, 2025
- K202607 — Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs · String King Lacrosse, LLC · Apr 23, 2021
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
March 18, 2026
O&M Halyard, Inc.
Anureet Singh
Regulatory Affairs Manager
1220 Old Alpharetta Rd.
Suite 320
Alpharetta, Georgia 30005
Re: K251967
Trade/Device Name: HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FXX
Dated: February 11, 2026
Received: February 12, 2026
Dear Anureet Singh:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251967 - Anureet Singh
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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 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-
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K251967 - Anureet Singh
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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
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| 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) K251967 | |
| Device Name HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | |
| Indications for Use (Describe) The HALYARD* FLUIDSHIELD* 3 Fog-Free 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. These are single use, disposable device(s), provided nonsterile. | |
| 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "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." | |
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HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Masks
Traditional 510(k) Premarket Notification
K251967
# 510(k) Summary K251967
Submitter: O&M Halyard, Inc.
1220 Old Alpharetta Rd, Suite 320
Alpharetta, GA 30005
Phone: 804-723-7000/800-488-8850
Fax: 804-723-7100
Regulatory Contact: Anureet Singh
Regulatory Affairs Manager
Date of Summary: 3 March 2026
Device Trade Name: HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT®
Lining and SO SOFT® Earloops; HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops with WrapAround Visor
Common Name: Surgical Mask
Classification Name: Mask, Surgical (21 CFR 880.4040, Product Code FXX)
Predicate Device: K111402 (KC300 Procedure Face Masks)
Device Description: The HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT®
Lining and SO SOFT® Earloops, and HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops with WrapAround Visor, are four-layer masks, constructed of well-known non-woven materials. Both masks are provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.
Indications for Use:
The HALYARD® FLUIDSHIELD® 3 Fog-Free 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. These are single use, disposable device(s), provided nonsterile.
Technological Characteristics Comparison Table:
| | Subject Device: (K251967) | 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 |
O&M Halyard, Inc.
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HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Masks
Traditional 510(k) Premarket Notification
K251967
| Device Trade Name | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | KC300 Procedure Mask, Fluidshield*, Fog-Free | Similar – The new trade name replaces the old one |
| --- | --- | --- | --- |
| Indication for Use | The HALYARD* FLUIDSHIELD* 3 Fog-Free 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. These are single use, disposable device(s), provided nonsterile. | The Kimberly-Clark, KC200 and KC300 Face Mask(s) is 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. | Similar – The new trade name replaces the old one |
| Material Composition for Non-Visor Mask | | | |
| Outer Layer | Blue Polypropylene Spunbond | Orange Polypropylene Spunbond | Similar |
| Second Layer | White Polypropylene Spunbond | Orange Polypropylene Spunbond | Similar |
| Third Layer | White Polypropylene Meltblown | White Polypropylene Meltblown | Same |
| Inner Layer | Polyethylene Terephthalate (Polyester) /Polyethylene BICO | White Polyester Cellulose | Different |
| Top Binding | White Polyester Spunlace | White Polyester Spunlace | Same |
| Lower Binding | White Polyester Spunlace | White Polyester Spunlace | Same |
| Wire | Aluminum | Aluminum | Same |
| Foam | Blue Polyester Foam/Spunlaced Polyester Laminate | Blue Polyester Foam/Spunlaced Polyester Laminate | Same |
| Earloop | Polyester/Lycra | Polyester/Lycra | Same |
| On Mask Printing | Ink, blue | Ink, blue | Same |
| Design Attributes for Non-Visor Mask | | | |
| Style | Flat Pleated | Flat Pleated | Same |
| Dimension (width) | 6.875” ± 0.125” | 7” ± 0.125” | Similar |
| Dimension (length) | 3.625” ± 0.125” | 3.625” ± 0.125” | Same |
| Method for Bonding Layers | Ultrasonic bonding | Ultrasonic bonding | Same |
| Material Composition for Visor Mask | | | |
| Outer Layer | Blue Polypropylene Spunbond | Orange Polypropylene Spunbond | Similar |
| Second Layer | White Polypropylene Spunbond | Orange Polypropylene Spunbond | Similar |
| Third Layer | White Polypropylene Meltblown | White Polypropylene Meltblown | Same |
| Inner Layer | Polyethylene Terephthalate (Polyester) /Polyethylene BICO | White Polyester Cellulose | Different |
| Top Binding | White Polypropylene Spunbond | White Polypropylene Spunbond | Same |
| Lower Binding | White Polyester Spunlace | White Polyester Spunlace | Same |
| Wire | Aluminum | Aluminum | Same |
| Foam | Blue Polyester Foam/Spunlaced Polyester Laminate | Blue Polyester Foam/Spunlaced Polyester Laminate | Same |
O&M Halyard, Inc.
Page 2
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HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Masks
Traditional 510(k) Premarket Notification
K251967
| Earloop | Polyester/Lycra | Polyester/Lycra | Same |
| --- | --- | --- | --- |
| Visor with Binding | Polyester Film with Black Polyester Spunlace | Polyester Film with Black Polyester Spunlace | Same |
| Design Attributes for Visor Mask | | | |
| Style | Flat Pleated | Flat Pleated | Same |
| Dimension (width) | 6.875” ± 0.125” | 6.875” ± 0.125” | Same |
| Dimension (length) | 3.625” ± 0.125” | 3.625” ± 0.125” | Same |
| Method for Bonding Layers | Ultrasonic bonding | Ultrasonic bonding | Same |
| Performance Data/Product Claims | | | |
| ASTM F2100 Level | 3 | 3 | Same |
| EN14683 Type | IIR | N/A | Different |
| Biocompatibility ISO 10993 | Non-sensitizing Not acutely toxic Non-Irritating | Non-sensitizing Not acutely toxic Non-Irritating | Same |
| Single Use Device | Yes | Yes | Same |
| Shelf Life | 5 year | N/A | Different |
Summary of Non-Clinical Performance Testing
Performance Testing
(Bench):
Performance testing of the HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops, and the HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops with WrapAround Visor, was evaluated, and the results showed that acceptance criteria were met.
| Purpose | Test | Acceptance Criteria | Result |
| --- | --- | --- | --- |
| Face Mask Performance | ASTM F2100 | ASTM F2100 Level 3 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥98% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥98% | Pass |
| Differential Pressure | EN 14683 | <6.0 mm H2O/cm2 | Pass |
| Fluid Resistance | ASTM F1862 | 160 mmHg | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass |
| Microbial Cleanliness | ISO 11737-1 | ≤30 cfu/g | Pass |
| Biocompatibility | ISO 10993 | | Pass |
| Systemic Toxicity | ISO 10993-11 Systemic Injection Test | Under the conditions of the testing, no signs of acute toxicity | Pass |
| Sensitization | ISO 10993-10 Kligman/Guinea Pig Maximization Test | Under the conditions of the testing, non-sensitizing 0% sensitization | Pass |
| Irritation | ISO 10993-23 Intracutaneous Injection Test | Under the conditions of the testing, non-irritating and no significant biological reaction | Pass |
| Cytotoxicity | ISO 10993-5 L929 MEM Elution Test | Under the conditions of the testing of the mask body, non-cytotoxic | Pass |
Performance Testing
O&M Halyard, Inc.
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HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Masks
Traditional 510(k) Premarket Notification
K251967
(Clinical):
No clinical testing required to support the submission.
Conclusions:
The conclusions drawn from the non-clinical tests demonstrate that the subject device, the HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops; HALYARD® FLUIDSHIELD® 3 Fog-Free Procedure Mask with SO SOFT® Lining and SO SOFT® Earloops with WrapAround Visor, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the KC300 Procedure Face Masks (K111402).
O&M Halyard, Inc.
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