HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

K232806 · Owens & Minor (O&M) Halyard, Inc. · FXX · Jun 7, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232806
• Device Name: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
• Applicant: Owens & Minor (O&M) Halyard, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) 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 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.

Device Story

Three-layer pleated procedure masks; constructed of non-woven materials (spunbond/meltblown polypropylene); includes malleable nosepiece and earloops. Designed for single-use, non-sterile, disposable application in clinical settings. Protects wearer and patient from blood, body fluids, and microorganisms. Performance meets ASTM F2100 Level 1 standards. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only: ASTM F2101 (BFE ≥95%), ASTM F2299 (PFE ≥95%), ASTM F1862 (80 mmHg fluid resistance), EN 14683 (breathability <5.0 mmH2O/cm2), 16 CFR 1610 (Class 1 flame resistance), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

Three-layer construction: outer spunbond polypropylene, middle meltblown polypropylene, inner layer (polyethylene/polyester or spunbond polypropylene). Features polyester/lycra earloops and polyethylene-coated steel nose wire. Dimensions 6.875" x 3.625". Non-sterile, single-use. Meets ASTM F2100 Level 1 performance requirements.

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

• Kimberly-Clark KC100 Face Masks (K110455)

Submission Summary (Full Text)

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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 7, 2024

Owens & Minor (O&M) Halyard, Inc. Anureet Singh Regulatory Affairs Manager 9120 Lockwood Blvd Mechanicsville, Virginia 23116

## Re: K232806

Trade/Device Name: HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2024 Received: April 26, 2024

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.

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 medical devices and radiation-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.

Allan Guan -S

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) K232806

#### Device Name

HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388)

#### Indications for Use (Describe)

The HALY ARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALY ARD* Level 1 Procedure Mask (48388) 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 HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Restricted Use (Part 21 CFR 801.2 Labeling)</div> |
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801.2 Labeling)</div> |

| | Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary — K232806

| Date of Summary | June 06, 2024 |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O&M Halyard, Inc.<br>9120 Lockwood Boulevard<br>Mechanicsville, VA 23116<br>Phone: [phone]<br>Fax: [phone] |
| Primary Contact for this<br>510(k) Submission | Anureet Singh<br>Regulatory Affairs Manager |
| Marketed Common Name | Surgical Mask and Procedure Mask |
| Device Submission Trade<br>Name and Description | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft<br>Earloops (25867)<br><br>HALYARD* Level 1 Procedure Mask (48388) |
| Device Product Code,<br>Class and<br>Classification Name | FXX<br>II<br>Surgical Mask (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 (yellow in color) Procedure Masks.<br>The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer<br>mask, constructed of well-known non-woven materials used in facial<br>protection. The Procedure Masks are provided with earloops and a malleable<br>nosepiece.<br><br>The ASTM F2100 Level 1 Procedure Masks that are the subject of this<br>submission are not provided with a fog-free foam or visor. These masks are<br>single use, disposable devices, provided non-sterile. |
| Indications for Use | The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft<br>Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to<br>be worn to protect both the patient and healthcare personnel from transfer of<br>microorganisms, body fluids, and particulate material. These face masks are<br>intended for use in infection control practices to reduce the potential exposure<br>of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1<br>Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD*<br>Level 1 Procedure Mask (48388) are single use, disposable device(s), provided<br>non-sterile. |

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| Technological Characteristics Comparison Table | | | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | Subject Device<br>HALYARD*FLUIDSHIELD* 1<br>Procedure Mask with So<br>Soft Lining and So Soft<br>Earloops (25867) | Subject Device<br>HALYARD* Level 1<br>Procedure Mask<br>(48388) | Predicate Device<br>KC100 Face Masks<br>(K110455) | Comparison |
| 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 | HALYARD* FLUIDSHIELD* 1<br>Procedure Mask with So<br>Soft Lining and So Soft<br>Earloops (25867) | HALYARD* Level 1<br>Procedure Mask<br>(48388) | KC100 Procedure<br>Mask | Different |
| Indications for<br>Use | The HALYARD*<br>FLUIDSHIELD* 1<br>Procedure Mask with So<br>Soft Lining and So Soft<br>Earloops (25867) is<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 masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure of the wearer to<br>blood and body fluids. The<br>HALYARD* FLUIDSHIELD* 1<br>Procedure Mask with So<br>Soft Lining and So Soft<br>Earloops (25867) is a single<br>use, disposable device,<br>provided non- sterile. | The HALYARD* Level 1<br>Procedure Mask<br>(48388) is intended to<br>be worn to protect<br>both the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the potential<br>exposure of the<br>wearer to blood and<br>body fluids. The<br>HALYARD* Level 1<br>Procedure Mask<br>(48388) is a single use,<br>disposable device,<br>provided<br>non-sterile. | The Kimberly-Clark<br>KC100 Face Mask(s) is<br>intended to be worn<br>to protect both the<br>patient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended<br>for use in infection<br>control practices to<br>reduce the potential<br>exposure of the<br>wearer to blood and<br>body fluids. The<br>Kimberly-Clark KC100<br>face mask(s) is a single<br>use, disposable<br>device(s), provided<br>non-sterile. | Same<br>The device<br>trade names<br>are different |
| Over-the-<br>Counter /<br>Prescription | OTC | OTC | OTC | Same |
| | | Design Attributes | | |
| Number of<br>Layers | 3 | 3 | 3 | Same |
| Color | Yellow | Yellow | 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 polypropylene | Meltblown<br>polypropylene | Meltblown<br>polypropylene | Same |
| Inner Layer | Polyethylene/polyester | Spunbond<br>polypropylene | Polyethylene/polyester | Different |
| Bindings | Polyester spunlace | Spunbond<br>polypropylene | Spunbond<br>polypropylene or<br>polyester spunlace | Same |
| Earloop | Polyester/lycra | Polyester/lycra | Polyester/lycra | Same |
| Nose wire | Polyethylene coated steel | Polyethylene coated<br>steel | Aluminum or<br>polyethylene coated<br>steel | 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 | Yes | Yes | No | Different |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Fluid 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 | $\ge 95%$ | $\ge 95%$ | $\ge 95%$ | Same |
| Flame<br>Resistance<br>16 CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
| ISO 10993-5 | Under the conditions of the<br>testing, not cytotoxic | Under the conditions of<br>the testing, not<br>cytotoxic | Under the conditions<br>of the testing, not<br>cytotoxic | Same |
| ISO 10993-10 | Under the conditions of the<br>testing, not a sensitizer and<br>not an irritant | Under the conditions of<br>the testing, not a<br>sensitizer and not an<br>irritant | Under the conditions<br>of the testing, not a<br>sensitizer and not an<br>irritant | Same |

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HALYARD* FLUIDSHIELD* 1 Procedure Mask (25867); HALYARD* Level 1 Procedure Mask (48388) Premarket Notification 510(k) K232806

O&M Halyard, Inc.

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HALYARD* FLUIDSHIELD* 1 Procedure Mask (25867); HALYARD* Level 1 Procedure Mask (48388) Premarket Notification 510(k) K232806

## Summary of Non-Clinical Testing:

| Test | Purpose | Criteria | Result |
|----------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|--------|
| ASTM F2101 | To demonstrate adequate<br>bacterial filtration efficiency | Under the conditions of the study,<br>at least 95% efficiency | Pass |
| EN 14683:2019+AC Annex C | To demonstrate acceptable<br>breathability | Under the conditions of the study,<br>at most 5.0 mm H₂O/cm² | Pass |
| ASTM F2299 | To demonstrate adequate<br>particulate filtration efficiency | Under the conditions of the study,<br>at least 95% efficiency | Pass |
| ASTM F1862 | To demonstrate adequate<br>resistance to liquids | Under the conditions of the study,<br>passing at 80 mmHg conditions | Pass |
| 16 CFR 1610 | To evaluate flame spread<br>resistance | Class 1 under the conditions of<br>the testing | Pass |
| ASTM F2100-19 | To evaluate mask performance | Level 1 under the conditions of<br>the evaluation | Pass |
| ISO 10993-5 | To evaluate the cytotoxic<br>potential of the mask | Under the conditions of the study,<br>non-cytotoxic | Pass |
| ISO 10993-10 Sensitization | To evaluate the sensitization<br>potential of the mask | Under the conditions of the study,<br>not a sensitizer | Pass |
| ISO 10993-10 Irritation | To evaluate the irritation<br>potential of the mask | Under the conditions of the study,<br>not an irritant | Pass |

### Summary of Clinical Testing

No clinical testing was performed in support of this submission.

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### Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the HALYARD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are as safe, as effective and perform as well as or better than the legally marketed predicate device KC100 Face Masks (K110455).