The Kimberly-Clark KC100 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 KC100 face mask(s) is a single use, disposable device(s), provided non-sterile.

Device Description

The Kimberly-Clark KC100 Procedure Mask(s) is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester. The mask is provided with earloops or ties in either knifted polyester/lycra or nonwoven polyester. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose and may or may not contain a fog free strip. Kimberly-Clark KC100 Procedure Mask(s) will be provided in a variety of colors, with and without a protective visor. Kimberly-Clark KC100 Procedure Mask(s) is a single use, disposable device, provided non-sterile.

AI/ML Overview

The acceptance criteria and study proving K110455 device meets those criteria are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Standard	Title	Acceptance Criteria	Reported Device Performance
Mil-M369454C	Military Specifications: Surgical Mask, disposable 1992	Not explicitly stated as an acceptance criterion in the provided text, but implies compliance with military specifications for surgical masks.	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." This statement broadly covers compliance with this standard.
ASTM F2101-07	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus	Not explicitly stated in the provided text, but generally, acceptance criteria for BFE are a minimum percentage (e.g., ≥ 95% or ≥ 98%) depending on the mask type.	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria."
PSC CS-191-53	Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles	Not explicitly stated in the provided text, but relates to flammability resistance (e.g., Class 1 for fabrics).	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria."
ASTM F2299	Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres	Not explicitly stated in the provided text, but generally involves a minimum particle filtration efficiency (e.g., ≥ 95% for 0.1 µm particles).	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria."
ISO 10993	Standards for evaluating the biocompatibility of a medical device	Not explicitly stated in the provided text, but implies the device passed various biocompatibility tests (e.g., cytotoxicity, irritation, sensitization).	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria."
F 1862	Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood	Not explicitly stated in the provided text, but would typically involve a specific level of resistance to synthetic blood penetration (e.g., passing at a certain pressure).	"All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria."

Note: While the document states "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria," the specific quantitative acceptance criteria for each standard are not explicitly detailed in the provided text. These would typically be defined within the test protocols for each standard.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample sizes used for the test set for each of the listed standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). Safety and performance testing of medical devices like masks is typically performed prospectively, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and testing. The "ground truth" for mask performance testing is established by objective measurements against standardized test methods (e.g., measuring BFE with a particle counter, resistance to blood penetration under specific pressure). It does not involve expert consensus on visual interpretations or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation of mask performance is based on objective, standardized tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (surgical mask) and its performance based on laboratory testing, not human-AI interaction for interpretation.

6. Standalone Performance Study

This document describes standalone performance testing for the physical device itself (Kimberly-Clark KC100 Face Masks). The tests performed (BFE, particle filtration, flammability, synthetic blood penetration, biocompatibility) are all designed to evaluate the mask's inherent protective properties and material characteristics in a laboratory setting, without human interaction. Therefore, a standalone performance study was done for the device.

7. Type of Ground Truth Used

The ground truth used for these studies is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., BFE measured by specific equipment, particle penetration quantified by particle counters, flammability determined by burn rates, synthetic blood penetration by visual inspection at defined pressures, biocompatibility by cellular responses). It is not based on expert consensus, pathology, or outcomes data in the typical sense.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm requiring a training set. The performance is assessed through laboratory testing of physical samples.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for a physical device.

Summary

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K110455

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APR 2 9 2011

510(k) Summary

Date of Submission: December 13, 2010 Sponsor: Kimberly-Clark Address: 1400 Holcomb Bridge Rd, Roswell, GA30076 Contact: Ann Waterhouse, RAC Telephone: (678) 352-6719 Facsimile: (920) 225-3108

Name of Device: Kimberly-Clark, KC100 Mask KC100 Procedure Mask, Lavender, Blue, Yellow, Green, White KC100 Procedure Mask with visor, Lavender, Blue, Yellow, Green, White KC100 Procedure Mask with fog-free strip, Lavender, Blue, Yellow, Green, White KC100 Surgical Mask, Lavender, Blue, Yellow, Green, White KC100 Surgical Mask with visor, Lavender, Blue, Yellow, Green, White KC100 Surgical Mask with fog-free strip, Lavender, Blue, Yellow, Green, White

Common Name/Classification Name: Mask, Surgical

Classification: Class II Product Code: FXX Regulation Number: 878.4040 Panel: General & Plastic Surgery

Indication for Use Statement:

The Kimberly-Clark KC100 Procedure 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 KC100 Procedure Mask(s) is a single use, disposable devices, provided non-sterile.

Device Description:

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K110455

will be provided in a variety of colors, with and without a protective visor. Kimberly-Clark KC100 Procedure Mask(s) is a single use, disposable device, provided non-sterile.

Comparison to Predicate Devices:

Please reference section 11, substantial equivalence.

Predicate Device:

Crosstex Isolite, Isofluid, Ultra Fluid Resistant and Procedural Face K082258 Masks

The following tests were conducted in support of ASTM 2100 labeling:

Standard	Title
Mil- M369454C	Military Specifications: Surgical Mask, disposable 1992
ASTM F2101-07	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE)of Medical Face Mask Materials, Using a Biological Aerosol, StaphylococcusAureus
PSC CS-191- 53	Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles
ASTM F2299	Standard Test Method for Evaluating the Initial Efficiency of Materials Used inMedical Masks to Penetration of Particulates Using Latex Spheres
ISO 10993	Standards for evaluating the biocompatibility of a medical device
F 1862	Test Method for Resistance of Medical Face Masks to Penetration bySynthetic Blood

All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria.

Conclusions:

The Kimberly-Clark KC100 Procedure Mask(s) have the same or similar intended use and technological characteristics as the predicate devices. Bench testing demonstrates the safety and efficacy of the Face Mask to consensus standards and other relevant standards. The Kimberly-Clark KC100 Procedure Mask(s) does not raise any new questions concerning safety and effectiveness. The Kimberly-Clark KC100 Procedure Mask(s) is comparable to the predicate device cited in terms of materials of composition, design, performance, and intended use. The Kimberly-Clark KC100 Procedure Mask(s) is substantially equivalent to the referenced predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and the USA. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

APR 2 9 2011

Kimberly-Clark Corporation C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747

Re: K110455

Trade/Device Name: Kimberly-Clark K-C100 Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: April 15, 2011 Received: April 18, 2011

Dear Mr. Conry:

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. Conry

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 (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

James DiRosario

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

Enclosure

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Indications for Use

510(k) Number (if known): K110455

Device Name:

Kimberly-Clark KC100 Face Masks

Indications For Use:

KC100 Procedure Mask, Lavender, Blue, Yellow, Green, White KC100 Procedure Mask with visor, Lavender, Blue, Yellow, Green, White KC100 Procedure Mask with fog-free strip, Lavender, Blue, Yellow, Green, White KC100 Surgical Mask, Lavender, Blue, Yellow, Green, White KC100-Surgical Mask with visor, Lavender, Blue; Yellow, Green, White KC100 Surgical Mask with fog-free strip, Lavender, Blue, Yellow, Green, White

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (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)

Rohit for EFC
(Division Sign-Off) 4/29/2021

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110455

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.