FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

K232777 · Owens & Minor (O&M) Halyard, Inc. · FXX · Jul 1, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232777
• Device Name: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
• Applicant: Owens & Minor (O&M) Halyard, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The FLUIDSHIELD* 1 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 intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

Device Story

Single-use, disposable, non-sterile procedure masks; intended for healthcare personnel and patient protection. Three-layer construction: spunbond polypropylene outer layer; meltblown polypropylene middle layer; polyethylene/polyester inner layer. Features include malleable nosepiece; some models include polyester film visor and blue polyester nose foam. Worn via polyester/lycra earloops. Used in clinical settings for infection control. Provides physical barrier against fluids and particulates; reduces cross-contamination risk.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including bacterial filtration efficiency (ASTM F2101), particulate filtration efficiency (ASTM F2299), fluid resistance (ASTM F1862), breathability (EN 14683), flame resistance (16 CFR 1610), bioburden (EN ISO 11737-1), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Three-layer pleated mask. Materials: spunbond polypropylene (outer), meltblown polypropylene (middle), polyethylene/polyester (inner). Components: polyester/lycra earloops, polyethylene-coated steel/aluminum nose wire, polyester film visor (select models), polyester nose foam (select models). Performance: ASTM F2100 Level 1, fluid resistance 80 mmHg, BFE/PFE ≥ 95%, differential pressure < 5.0 mmH2O/cm². Non-sterile, single-use.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce potential exposure to blood, body fluids, microorganisms, 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

• Kimberly-Clark KC100 Face Masks (K110455)

Submission Summary (Full Text)

{0}------------------------------------------------

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 1, 2024

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

## Re: K232777

Trade/Device Name: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 16, 2024 Received: May 17, 2024

Dear Caitlin Senter:

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.

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

anıl

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

{2}------------------------------------------------

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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K232777

#### Device Name

FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

#### Indications for Use (Describe)

The FLUIDSHIELD* 1 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 intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input type="checkbox"/> Presentation Use (21 CFR 201.66) - Direct to Consumer | <input checked="" type="checkbox"/> Sample Compounding (21 CFR 201.66) - Compounding |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in gray. The ampersand symbol is placed between the two words.

# 510(k) Summary – K232777

| Date of Summary | July 1, 2024 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc. |
| | 1 Edison Drive |
| | Alpharetta, GA 30005 |
| Primary Contact for this | Caitlin Senter, MS, RAC |
| 510(k) Submission | Tel: [phone] |
| | Email: [e-mail] |
| Marketed Common Name | Procedure Mask |
| Device Submission Trade<br>Name and Description | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,<br>Lavender (25868); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT*<br>Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) |
| Device Product Code,<br>Class and<br>Classification Name | FXX<br>II<br>Surgical Apparel (21 CFR 878.4040) |
| Predicate Device | K110455<br>Kimberly-Clark KC100 Face Masks<br>FXX Surgical Mask<br>Surgical Apparel (21 CFR 878.4040) |
| Subject Device Description | The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure<br>Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a<br>three-layer mask, constructed of well-known non-woven materials used in<br>facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining<br>and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The<br>FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*<br>Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose<br>foam.<br>These masks are single use, disposable devices, provided non-sterile. |
| Indications for Use | The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both<br>the patient and healthcare personnel from transfer of microorganisms, body<br>fluids, and particulate material. These face masks are intended for use in<br>infection control practices to reduce the potential exposure of the wearer to<br>blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use,<br>disposable device(s), provided non-sterile. |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name of the company, "Owens & Minor", in a light gray color.

| Technological Characteristics Comparison Table | | | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Subject Device | Subject Device | Predicate Device | Comparison |
| | FLUIDSHIELD* 1<br>Procedure Mask with SO<br>SOFT* Lining and SO<br>SOFT* Earloops, Lavender<br>(25868) | FLUIDSHIELD* 1 Fog-Free<br>Procedure Mask with<br>SOO SOFT* Lining and SO<br>SOFT* Earloops,<br>Lavender, Wrap Around<br>Visor (41798) | KC100 Face Masks<br>(K110455) | |
| FDA Product<br>Code | FXX | FXX | FXX | Same |
| FDA<br>Classification | Class II | Class II | Class II | Same |
| Regulation<br>Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Surgical Mask | Same |
| Device Trade<br>Name | FLUIDSHIELD* 1<br>Procedure Mask with SO<br>SOFT* Lining and SO<br>SOFT* Earloops,<br>Lavender (25868) | FLUIDSHIELD* 1 Fog-Free<br>Procedure Mask with SO<br>SOFT* Lining and SO<br>SOFT* Earloops,<br>Lavender, Wrap Around<br>Visor (41798) | KC100 Procedure<br>Mask | Different |
| Indications for<br>Use | The FLUIDSHIELD* 1<br>Procedure Mask(s) are<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure of the<br>wearer to blood and<br>body fluids.<br>FLUIDSHIELD* 1<br>Procedure Mask(s) are<br>single use, disposable<br>device(s), provided non-<br>sterile. | The FLUIDSHIELD* 1<br>Procedure Mask(s) are<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure of the<br>wearer to blood and<br>body fluids.<br>FLUIDSHIELD* 1<br>Procedure Mask(s) are<br>single use, disposable<br>device(s), provided non-<br>sterile. | The Kimberly-Clark<br>KC100 Face Mask(s)<br>is intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the<br>potential exposure<br>of the wearer to<br>blood and body<br>fluids. The<br>Kimberly-Clark<br>KC100 face mask(s)<br>is a single use,<br>disposable<br>device(s), provided | Same<br>The device<br>trade<br>names are<br>different |
| | | | non-sterile. | |
| Over-the-<br>Counter / | ОТС | ОТС | ОТС | Same |
| Prescription | | | | |
| | | Design Attributes | | |
| Number of<br>Layers | 3 | 3 | 3 | Same |
| Color | Lavender | Lavender | Yellow, blue, green,<br>white, lavender | Same |
| Style | Pleated with earloops | Pleated with earloops | Pleated with earloops | Same |
| Outer Layer | Spunbond polypropylene | Spunbond<br>polypropylene | Spunbond<br>polypropylene | Same |
| Middle Layer | Meltblown<br>polypropylene | Meltblown<br>polypropylene | Meltblown<br>polypropylene | Same |
| Inner Layer | Polyethylene/polyester | Polyethylene / polyester | Polyethylene /<br>polyester | Same |
| Bindings | Polyester spunlace /<br>polyester spunbond | Polyester spunlace /<br>polyester spunbond | Polyester spunlace /<br>polyester spunbond | Same |
| Earloop | Polyester/lycra | Polyester / lycra | Polyester / lycra | Same |
| Nose wire | Polyethylene coated steel<br>wire / malleable<br>aluminum | Polyethylene coated<br>steel wire / malleable<br>aluminum | Aluminum or<br>polyethylene coated<br>steel | Same |
| Visor | None | Polyester film | Includes models with<br>polyester film visor<br>and models without a<br>visor | Same |
| Nose Foam | None | Blue polyester foam | Includes models with<br>blue polyester nose<br>foam and models<br>without nose foam | Same |
| Mask<br>Dimension<br>Length | 6.875" ± 0.125" | 6.875" ± 0.125" | 6.875" ± 0.125" | Same |
| Mask<br>Dimension<br>Width (Flat) | 3.625" +/-0.125" | 3.625" +/-0.125" | 3.625" +/- 0.125" | Same |
| | | Performance Data/Product Claims | | |
| ASTM F2100<br>Level | 1 | 1 | 1 | Same |
| EN 14683 | Type II | No | No | Different |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Fluid<br>Resistance<br>ASTM F1862 | 80 mmHg | 80 mmHg | 80 mmHg | Same |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Differential<br>pressure | < 5.0 mmH2O/cm² | < 5.0 mmH2O/cm² | < 5 mmH2O/cm² | Same |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Flame Resistance<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
| ISO 10993-5 | Under the conditions of<br>the testing, not cytotoxic | Under the conditions of<br>the testing, not cytotoxic | Under the conditions of<br>the testing, not cytotoxic | Same |
| ISO 10993-10 | Under the conditions of<br>the testing, not a<br>sensitizer and not an<br>irritant | Under the conditions of<br>the testing, not a<br>sensitizer and not an<br>irritant | Under the conditions of<br>the testing, not a<br>sensitizer and not an<br>irritant | Same |

O&M Halyard, Inc.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor.…