KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL

K111402 · Kimberly-Clark · FXX · Oct 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111402
• Device Name: KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
• Applicant: Kimberly-Clark
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Kimberly-Clark, KC200 and KC300 Face Mask(s) 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 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.

Device Story

Four-layer disposable face mask; constructed of nonwoven polyester blends and polypropylene; includes malleable nosepiece for fit; available with earloops or ties; optional protective visor. Used in clinical settings by healthcare personnel and patients to provide barrier protection against blood, body fluids, and particulates. Single-use, non-sterile device.

Clinical Evidence

Bench testing only. Tested per ASTM F2100-11, including Bacterial Filtration Efficiency (BFE) using Staphylococcus Aureus, flammability (16 CFR 1610), particulate penetration (ASTM F2299), synthetic blood penetration (ASTM F1862), and biocompatibility (ISO 10993). All results met acceptance criteria.

Technological Characteristics

Four-layer nonwoven polyester/polypropylene construction; malleable nosepiece; earloops or ties (knitted polyester/lycra or nonwoven polyester). Complies with ASTM F2100-11, ASTM F2100-07, ASTM F1862, ASTM F2299, and ISO 10993. 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 KC100 face mask(s) (K110455)

Submission Summary (Full Text)

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K111402

OCT 2 0 2011

# 510K Summary

| Date Summary was<br>Prepared: | May 17, 2011 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Ann Waterhouse, RAC<br>Associate Director of Regulatory Affairs<br>Roswell, GA 30076<br>678-352-6719 (telephone)<br>920-225-3108 (facsimile)<br>[e-mail] |
| Device Trade Name: | KC 200 Face Mask<br>KC 300 Face Mask |
| Device Common<br>names | Mask, surgical |
| Device Product<br>Codes and<br>Classification<br>Names: | FXX, Class II<br>Mask, surgical (21 CFR 878.4040) |
| Predicate Devices | The Kimberly-Clark KC100 face mask(s) subject of K110455. |
| Device Description: | The Kimberly-Clark Face Mask(s) is a four layer mask,<br>constructed of nonwoven polyester blends and pol ypropylene<br>materials. B indings are nonwoven polyester. The mask is<br>provided with earloops or ties in either knitted polyester/lycra or<br>nonwoven polyester. A malleable nosepiece is placed within the<br>bindings for comfort and individualized fit around the wearer's<br>nose. Kimberly-Clark KC200 and KC300 Face Mask(s) will be<br>provided with and w ithout a protective visor. Kimberly-Clark<br>Face Mask(s) is a single use, disposable device, provided non-<br>sterile. |
| Intended Use: | The Kimberly-Clark, KC200 and K C300 Face Mask(s) is<br>intended to be worn to protect both the patient and healthcare<br>personnel from transfer of microorganisms, body fluids, and<br>particulate material. These face masks are intended for use in<br>infection control practices to reduce the potential exposure of the<br>wearer to blood and body fluids. The Kimberly-Clark, KC200 and |

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KC300 face mask(s) is a s ingle use, disposable device(s), provided non-sterile.

### Technological Characteristics and Substantial Equivalence:

The Kimberly-Clark KC200 and K C300 face mask(s) are substantially equivalent to the predicate device, Kimberly-Clark KC100 face mask(s) of K110455 in intended use and principles of operation. The Kimberly-Clark KC200 and KC300 face mask(s) meet ASTM F1862 s tandards at a higher velocity synthetic blood penetration than the KC100 face mask(s). The difference in performance characteristics comply with ASTM 2100-11 and A STM F2100-07, and r aises no new issues of safety and efficacy.

Summary of Testing:

The KC200 and K C300 face mask(s) have been t ested 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, such as:

| Mil- M369454C | Military Specifications: Surgical Mask,<br>disposable 1992 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| PSC CS-191-53 | Flammability Test Method (16 CFR 1610) for<br>Flammability of Clothing Textiles |
| ASTM F 2299 | Standard Test Method for Evaluating the Initial<br>Efficiency of Materials Used in Medical Masks<br>to Penetration of Particulates Using Latex<br>Spheres |
| ISO 10993 | Standards for evaluating the biocompatibility of<br>a medical device |
| ASTM F 1862 | Test Method for Resistance of Medical Face<br>Masks to Penetration by Synthetic Blood |

All results of testing met acceptance criteria.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

#### Public Health Service

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

Ms. Ann Waterhouse, RAC Associate Director of Regulatory Affairs Kimberly-Clark 1400 Holcomb Bridge Road, Bldg. 300 Roswell, Georgia 30076

OCT 2 0 2011

Re: K111402

Trade/Device Name: Kimberly-Clark KC 200 Face Mask(s) Kimberly-Clark KC 300 Face Mask(s) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: October 6, 2011 Received: October 7, 2011

Dear Ms. Waterhouse:

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 - Ms. Waterhouse

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): _ K | | 402

Device Name:

Kimberly-Clark KC 200 Face Mask(s) Kimberly-Clark KC 300 Face Mask(s)

Indications for Use:

The Kimberly-Clark, KC200 and KC300 Face Mask(s) 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 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.

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 KC300 Surgical Mask, Fluidshield*, fog free KC300 Surgical Mask, Fluidshield*, fog free with visor

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eydith S. Clavien-Willis

Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111402