Fluidshield* Surgical Mask with Expanded Chamber

K143287 · Halyard Health, Inc. · FXX · Mar 24, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143287
• Device Name: Fluidshield* Surgical Mask with Expanded Chamber
• Applicant: Halyard Health, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 24, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Expanded Chamber Surgical Face Mask 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Device Story

Single-use, non-sterile surgical face mask with expanded chamber (duckbill) design; worn by healthcare personnel and patients. Constructed from nonwoven layers (polypropylene spunbond/meltblown, polyethylene/polyester inner layer). Protects against transfer of microorganisms, body fluids, and particulates. Available with or without integrated visor. Provides physical barrier to reduce exposure to blood and body fluids. Used in clinical settings for infection control. Output is a protective barrier; healthcare providers use it to maintain sterile fields and prevent cross-contamination. Benefits include reduced risk of pathogen transmission and fluid exposure.

Clinical Evidence

Bench testing only. Performance verified against ASTM F2100-11 Level 2 standards: differential pressure (MIL-M-36954C), particulate filtration (ASTM F2299), bacterial filtration (ASTM F2101), flammability (16 CFR Part 1610), fluid resistance (ASTM F1862), and biocompatibility (ISO 10993). All tests met acceptance criteria.

Technological Characteristics

Expanded chamber (duckbill) design; nonwoven polypropylene spunbond and meltblown layers; polyethylene/polyester inner layer. Dimensions: 7.5" width, 8.3" length. Meets ASTM F2100-11 Level 2 performance specifications. Biocompatible (non-cytotoxic, non-sensitizing, non-irritating). Non-sterile, single-use.

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 Level 2 face masks (K111402)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2015

Halyard Health, Inc. Mr. Roberto F. Refeca Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004

Re: K143287

> Trade/Device Name: FLUIDSHIELD* Surgical Mask with Expanded Chamber Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: February 24, 2015 Received: February 25, 2015

Dear Mr. Refeca.

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 (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. 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.

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Page 2 - Mr. Refeca

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K143287

Device Name

FLUIDSHIELD* Surgical Mask with Expanded Chamber

Indications for Use (Describe)

The Expanded Chamber Surgical Face Mask 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 intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

39123 Expanded Chamber Surgical Face Masks w/o Visor 39124 Expanded Chamber Surgical Face Mask with Visor

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510K Owner/<br>Application | Halyard Health, Inc.<br>5405 Windward Parkway<br>Alpharetta, GA 30004 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Roberto F. Refeca<br>Associate Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared | 03-24-2015 |
| Trade Name | FLUIDSHIELD* Surgical Mask with Expanded Chamber |
| Common Name | Surgical mask |
| Classification<br>Name | Surgical mask |
| Review Panel | General and Plastic Surgery |
| Device<br>Classification<br>and Product<br>Code | Class II per 21 CFR §878.4040<br>Product Code - FXX |

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The Halyard FLUIDSHIELD Surgical Mask with Expanded Chamber, the Predicate Device subject of this submission, is substantially equivalent to the Kimberly-Clark Level 2 face masks originally cleared in K111402.

| Component | Predicate Device KC200 & 300 Surgical<br>Mask (K111402) | | FLUIDSHIELD* Surgical Mask with<br>Expanded Chamber (Proposed Device) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KC200 | KC300 | |
| Intended<br>Use | The Kimberly-Clark, KC200 and KC300 Face<br>Mask(s) is intended to be worn to protect both<br>the patient and healthcare personnel from<br>transfer of microorganisms, body fluids, and<br>particulate material. These face masks are<br>intended for use in infection control practices<br>to reduce the potential exposure of the wearer<br>to blood and body fluids. The Kimberly-Clark,<br>KC200 and KC300 face mask(s) is a single<br>use, disposable device(s), provided non-sterile.<br>Same | | Same:<br><br>The Expanded Chamber Surgical Face<br>Mask is intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids and<br>particulate material. These face masks<br>are intended for use in infection control<br>practices to reduce the potential<br>exposure to blood and body fluids. This<br>is a single use, disposable device(s),<br>provided non-sterile. |
| Mask<br>Design | Flat Pleated | | Expanded Chamber (Duckbill) |
| Sterile | Non Sterile | | Non Sterile |
| Single Use | Yes | | Yes |
| Outer Facing | Polyester Cellulose<br>(Blue/Orange Print) | Orange<br>Polypropylene<br>Spunbond | Top Half: Blue Polypropylene<br>Spunbond (w Print)<br>Bottom Half: White Polypropylene<br>Spunbond |
| Spunbond<br>Middle<br>Layer | Polypropylene Spunbond | | Polypropylene Spunbond |
| Meltblown<br>Middle<br>Layer | Polypropylene Meltblown | | Polypropylene Meltblown |
| Inner Facing<br>Layer | Polyester Cellulose | | Polyethylene/Polyester |
| Component | Predicate Device KC200 & 300 (K111402) | | FLUIDSHIELD* Surgical Mask<br>with Expanded Chamber<br>(Proposed Device) |
| | KC200 | KC300 | |
| Top and<br>Bottom<br>Binding | Polyester Spunlace or Polypropylene Spunbond | | Polypropylene Spunbond |
| Ties | Polyester Spunlace | | Polyester Spunlace or<br>Polypropylene Spunbond |
| Branding | Kimberly-Clark, Markem Ink, Blue | | Halyard Branding (Colorant not<br>used, embossed logo) |
| Style | Flat-pleated | | Expanded Chamber |
| Offered with<br>Visor | Yes | | Yes |
| Product<br>Performance<br>Specificatio<br>ns | Meets ASTM F2100-11, ASTM<br>F1862-07, ASTM F2101-07,<br>ASTM F2299-03, MIL-<br>M369454C<br>16 CFR 1610 (PSC CS-191-53)<br>ASTM Level 2 Performance<br>(KC200) | Meets ASTM<br>F2100-11,<br>ASTM F1862-<br>07, ASTM<br>F2101-07,<br>ASTM F2299-<br>03, MIL-<br>M369454C<br>16 CFR 1610<br>(PSC CS-191-53)<br>ASTM Level 3<br>Performance<br>(KC300) | Meets ASTM F2100-11, ASTM<br>F1862-07, ASTM F2101-07,<br>ASTM F2299-03, MIL-M369454C<br>16 CFR 1610 (PSC CS-191-53)<br>ASTM Level 2 Performance<br>(KC200) |
| Biocompatib<br>ility | Biocompatible, Non-cytotoxic, Non-sensitizing,<br>Non-irritating | | Biocompatible, Non-cytotoxic,<br>Non-sensitizing, Non-irritating |
| Dimensions<br>Width<br>(Cheek to<br>Cheek) | 6.5" ± 0.75" | 6.5" ± 0.75" | 7.5" ± 0.11" |
| Dimensions<br>Length<br>(Nose to<br>Chin) | 4" ± 0.75" | 4" ± 0.75" | 8.3" ± 0.4" |

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| Device<br>Description | The product is a face mask utilizing an expanded chamber design consisting<br>of nonwoven spunbond, nonwoven meltblown, and nonwoven inside layer<br>material, nosepiece, and nonwoven ties and may be produced with or without<br>a visor. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Expanded Chamber Surgical Face Mask is intended to be worn to protect<br>both the patient and healthcare personnel from transfer of microorganisms,<br>body fluids and particulate material. These face masks are intended for use in<br>infection control practices to reduce the potential exposure to blood and body<br>fluids. This is a single use, disposable device(s), provided non-sterile. |
| Model<br>Numbers | 39123 Expanded Chamber Surgical Face Mask (w/o Visor)<br>39124 Expanded Chamber Surgical Face Mask (with Visor) |
| Technological<br>Characteristics | There FLUIDSHIELD* Surgical Mask with Expanded Chamber is<br>substantially equivalent to the current ASTM F2100-11 Level 2 Surgical<br>Mask (K111402), the product conforms with ASTM 2100-11 and the<br>Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notification<br>510K Submissions, issued March 5, 2004. |
| | Continued on next page |

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| Performance<br>Characteristic,<br>Level II per<br>ASTM F2100 | Applicable<br>Testing and/or<br>Referenced<br>Standard<br>(Method) | FLUIDSHIELD<br>Surgical Mask<br>with Expanded<br>Chamber |
|--------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------|
| Differential<br>Pressure mm<br>H2O/cm² | MIL-M-36954C | Met Acceptance<br>Criteria |
| PFE- Particulate<br>Filtration | ASTM F2299 | Met Acceptance<br>Criteria |
| BFE-Bacterial<br>Filtration | ASTM F2101 | Met Acceptance<br>Criteria |
| Flammability | 16 CFR Part 1610 | Met Acceptance<br>Criteria |
| Fluid Resistance,<br>synthetic<br>blood | ASTM F1862 | Met Acceptance<br>Criteria |
| Biocompatibility<br>(Mask and Visor) | ISO 10993 | Met Acceptance<br>Criteria |