(246 days)
Not Found
No.
The device is a surgical mask, which is a physical barrier and does not have any computational components that would incorporate an AI model. The text explicitly states that AI, DNN, or ML are "Not Found" and the device description details material construction.
No
The device is a surgical/procedure mask intended for protection against microorganisms, body fluids, and particulate material, not for treating a disease or medical condition.
No
Explanation: The device is described as a surgical/procedure mask intended to protect against transfer of microorganisms, body fluids, and particulate material. Its purpose is for infection control, not for diagnosing any medical condition.
No
The device is a physical product (surgical and procedure masks) made of non-woven materials, designed for physical protection and filtration, with no mention of software components or functionality.
No.
The device is a surgical mask, which is a physical barrier intended to protect against transfer of microorganisms and fluids, not for in-vitro diagnostic purposes.
N/A
Intended Use / 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.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Face Mask Performance: ASTM F2100, Acceptance Criteria: ASTM F2100 Level 3, Result: Pass (28800, 28804, 47137, 48207)
Bacterial Filtration Efficiency: ASTM F2101, Acceptance Criteria: >=98%, Result: Pass
Particulate Filtration Efficiency: ASTM F2299, Acceptance Criteria: >=98%, Result: Pass
Differential Pressure: EN 14683, Acceptance Criteria: =98%
Particulate Filtration Efficiency: >=98%
Differential Pressure:
§ 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.
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
Page 3
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 320 | |
| Alpharetta, Georgia 30005 | |
| Primary Contact for this 510(k) Submission | Angela L. Bunn, RAC |
| Tel: 470‐347‐7147 | |
| Email: angela.bunn@owens‐minor.com | |
| Marketed Common Name | Surgical Mask and Procedure Mask |
| Device Submission Trade Name | Surgical Masks |
| 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) |
Procedure Masks
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) |
| 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. |
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 Masks | ||
| 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) | KC200 Procedure Mask | ||
| KC200 Procedure Mask, fog‐free with visor | |||
| KC200 Surgical Mask, fog‐free | |||
| KC200 Surgical Mask, fog‐free with visor | |||
| KC300 Procedure Mask, Fluidshield*, fog‐free | |||
| KC300 Procedure Mask, Fluidshield*, fog‐free with visor | Similar | ||
| There 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 Masks
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) | KC300 Surgical Mask, Fluidshield*, fog‐free
KC300 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. | Same |
This 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 |
Page 5 of 6
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 |