KC 300 SURGICAL MASK

K131879 · Kimberly-Clark Corp. · FXX · Dec 20, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131879
• Device Name: KC 300 SURGICAL MASK
• Applicant: Kimberly-Clark Corp.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Kimberly-Clark KC300 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 intended for use in infection 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

Kimberly-Clark KC300 Face Mask is a single-use, disposable, non-sterile surgical mask; intended for use by healthcare personnel and patients in clinical settings for infection control. Device acts as a physical barrier to reduce transfer of microorganisms, body fluids, and particulate material. Construction consists of four layers: outer facing layer (polyethylene/polyester), spunbond middle layer (polypropylene), meltblown middle layer (polypropylene), and inner facing layer (polyethylene/polyester). Device features flat-pleated style; available in procedure and surgical configurations; some models include fog-free features or visors. Healthcare providers wear the mask to protect themselves and patients during procedures. Benefit is reduced potential exposure to blood and body fluids, supporting standard infection control practices.

Clinical Evidence

Bench testing only. No clinical data. Testing included Bacterial Filtration Efficiency (BFE) per ASTM F2100-11, fluid resistance per ASTM F1862, particulate filtration per ASTM F2299, flammability per 16 CFR 1610, and biocompatibility per ISO 10993. All results met acceptance criteria.

Technological Characteristics

Four-layer construction: polyethylene/polyester outer/inner layers, polypropylene spunbond/meltblown middle layers. Polyester/Lycra earloops or polypropylene ties. Dimensions: 6.5" x 4". Meets ASTM F2100-11, ASTM F1862-07, ASTM F2101-07, ASTM F2299-03, MIL-M36954C, and 16 CFR 1610. Biocompatible (non-cytotoxic, non-sensitizing, non-irritating). Non-sterile, single-use.

Indications for Use

Indicated for use by healthcare personnel and patients as a protective barrier against microorganisms, body fluids, and particulate material in infection control settings to reduce exposure to blood and body fluids. Single-use, disposable, non-sterile.

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 KC300 Face Mask (K111402)
• Kimberly-Clark KC100 Face Mask (K110455)

Submission Summary (Full Text)

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# KI 31879

DEC 2 0 2013

### 510(K) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

- Kimberly-Clark* 510(K) Owner/ 1400 Holcomb Bridge Road APPLICANT Roswell, GA 30076 Contact Person Monica King, MBA Associate Director, Regulatory Affairs Tel: [phone]
Fax: [phone] email: [e-mail]

- DATE PREPARED: December 20, 2013
- Trade Name: Kimberly-Clark* KC300 Face Mask

Common Name: Surgical mask

Classification Surgical mask NAME:

| DEVICE | Class II per 21 CFR §878.4040 |
|----------------------------------------|-------------------------------|
| CLASSIFICATION<br>AND PRODUCT<br>CODE: | Product Code - FXX |

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# PREDICATE DEVICES:

The Kimberly-Clark* KC300 face mask, the subject of this submission, is substantially equivalent to the Kimberly-Clark face masks originally cleared in K110455 and K11402.

| Component | Predicate Device<br>KC300 (K111402) | Predicate Device<br>(K110455) | KC300 (Proposed<br>Device) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Kimberly-Clark,<br>K0200 and KC300<br>Face Mask(s) is<br>intended to be worn<br>to protect both the<br>patient and<br>healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate material.<br>These face masks<br>are intended for use<br>in infection control<br>practices to reduce<br>the potential<br>exposure of the<br>wearer to blood and<br>body fluids. The<br>Kimberly-Clark,<br>KC200 and KC300<br>face mask(s) is a<br>single use,<br>disposable<br>device(s), provided<br>non-sterile. | The Kimberly-Clark<br>KC100 Face Mask(s) is<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids, and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure of<br>the wearer to blood<br>and body fluids. The<br>Kimberly-Clark KC100<br>face mask(s) is a single<br>use, disposable<br>device(s), provided<br>non-sterile. | The Kimberly-Clark<br>KC300 Face Mask is<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single use,<br>disposable device(s),<br>provided non-sterile.<br><br>Product Code 47297,<br>KC300 FLUIDSHIELD*<br>Procedure Mask with<br>SO SOFT* Lining<br>Product Code 47298,<br>KC300 FLUIDSHIELD*<br>Fog-Free Procedure<br>Mask with SO SOFT*<br>Lining<br>Product Code 48297,<br>KC300 FLUIDSHIELD*<br>Surgical Mask with SO<br>SOFT* Lining |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes | Yes |
| Outer Facing<br>Layer | Polypropylene<br>Spunbond<br>no print | Polypropylene<br>Spunbond<br>no print | Polyethylene/Polyester,<br>with pink and blue ink<br>print |
| Spunbond Middle<br>Layer | Polypropylene<br>spunbond | N/A (Three layer mask) | Polypropylene<br>spunbond |
| Meltblown Middle<br>Layer | Polypropylene<br>Meltblown | Polypropylene<br>Meltblown | Polypropylene<br>Meltblown |
| Inner Facing<br>Layer | Polyester cellulose | Polyethylene/Polyester | Polyethylene/Polyester |
| Top and Bottom<br>Binding | Polyester Spunlace | Polyester Spunlace | Polyester Spunlace,<br>or<br>Polypropylene<br>spunbond |
| Earloop | Polyester/Lycra<br>Knitted | Polyester/Lycra Knitted | Polyester/Lycra Knitted |
| Ties | Polyester Spunlace | Polyester Spunlace | Polypropylene<br>spunbond |
| Kimberly-Clark<br>Branding | Markem Ink, Blue | Markem Ink, Blue | Markem Ink, Blue |
| Style | Flat-pleated | Flat-pleated | Flat-pleated |
| Offered as fog<br>free | Yes | Yes | Yes |
| Offered with<br>Visor | Yes | Yes | Yes |
| Product<br>Performance<br>Specifications | Meets ASTM<br>F2100-11, ASTM<br>F1862-07, ASTM<br>F2101-07, ASTM<br>F2299-03, MIL-<br>M369454C<br>16 CFR 1610 (PSC<br>CS-191-53) | Meets ASTM F2100-<br>11, ASTM F1862-07,<br>ASTM F2101-07,<br>ASTM F2299-03, MIL-<br>M369454C<br>16 CFR 1610 (PSC<br>CS-191-53) | Meets ASTM F2100-<br>11, ASTM F1862-07,<br>ASTM F2101-07,<br>ASTM F2299-03, MIL-<br>M369454C<br>16 CFR 1610 (PSC<br>CS-191-53) |
| Biocompatibility | Biocompatible. Non-<br>cytotoxic, Non-<br>sensitizing, Non-<br>irritating | Biocompatible. Non-<br>cytotoxic, Non-<br>sensitizing, Non-<br>irritating | Biocompatible. Non-<br>cytotoxic, Non-<br>sensitizing, Non-<br>irritating |
| Dimensions-<br>width | 6 5" ± 0.75" | 6 5" ± 0.75" | 6 5" ± 0.75" |
| Dimension-<br>length | 4" ± 0.75" | 4" ± 0.75" | 4" ± 0.75" |

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DEVICE DESCRIPTION: The Kimberly-Clark* KC 300 Face Mask is a four layer mask, constructed of polyester and polypropylene materials. The outer facing layer is currently made of polypropylene spunbond fabric. With the proposed change, the outer facing layer will be made of polyethylene/polyester material used in a predicate device. The inner facing layer is currently made of polyester cellulose. With the proposed change, the inner facing layer will also be made of polyethylene/polyester material used in a predicate device. Kimberly-Clark KC300 Face Mask(s) is a single use, disposable device, provided nonsterile.

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INTENDED USE: The Kimberly-Clark KC300 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Product Code 47297, KC300 FLUIDSHIELD* Procedure Mask with SO SOFT* Lining Product Code 47298, KC300 FLUIDSHIELD* Fog-Free Procedure Mask with SO SOFT* Lining

Product Code 48297, KC300 FLUIDSHIELD* Surgical Mask with SO SOFT* Lining

TECHNOLOGICAL CHARACTERISITICS: The difference in performance characteristics conform with ASTM 2100-11 and ASTM 2100-07 and raise no new issues of safety and efficacy.

PERFOMANCE TESTING: The KC300 face mask(s) have been tested according to:

- . ASTM 2100-11 and standards which comprise ASTM F2100-11, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus
- Mil- M36954C Military Specifications .
- . 1992 PSC CS-191- 53 Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles
- . ASTM F 2299 Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks

to Penetration of Particulates Using Latex Spheres

- ISO 10993 Standards for evaluating the biocompatibility of . a medical device
- ASTM F 1862 Test Method for Resistance of Medical Face Masks to Penetration by . Synthetic Blood

SUMMARY OF TEST RESULTS: All results of testing met acceptance criteria.

CONCLUSIONS: The conclusions drawn from the non-clinical tests demonstrate that the device is as safe and as effective, and performs as well as the legally marketed device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, emphasizing its official and governmental nature.

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

December 20, 2013

Kimberly-Clark* Corporation Ms. Monica King Associate Director of Regulatory Affairs 1400 Holcomb Bridge Road ROSWELL GA 30076

Re: K131879

Trade/Device Name: Kimberly-Clark KC 300 Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: November 19, 2013 Received: November 20, 2013

## Dear Ms. King:

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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· 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

Sincerely yours.

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: The image shows a signature and some text. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The signature is illegible.

Erin I. Keith, M.S. Acting 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES ੱ Food and Drug Administration

Indications for Use

510(k) Number (if known) K131879

Device Name

Kimberly-Clark KC300 Face Mask

#### Indications for Use (Describe)

The Kimberly-Clark KC300 Face Mask is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate masks are intended for use in infection control precies to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterlie.

Product code 47297, KC300 FLUIDSHIELD* Procedure Mask with SO SOFT® Lining Product code 47298, KC300 FLUIDSHIELD® Fog-Free Procedure Mask with SO SOFT® Lining Product code 48297 KC300 FLUIDSHIELD* Surgical Mask with SO SOFT* Lining

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth F. Claverie -S 2013.12.20 14:55:29 -05'00'

FORM FDA 3881 (9/13)

CDD (1) 423-62-5 PEC Pu

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 --See PRA Statement on last page.