Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical face mask and its materials, with performance testing focused on filtration efficiency and material properties. There is no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is intended to protect against the transfer of microorganisms and fluids, not to treat a disease or condition.

Diagnostic

No

Explanation: The device is a face mask intended to protect against transfer of microorganisms and fluids, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical face mask constructed of polyester and polypropylene materials, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description focuses on the physical construction and materials of the mask.
Performance Studies: The performance studies listed are related to the mask's ability to filter particles and fluids, its flammability, and biocompatibility. These are all relevant to its function as a physical barrier and protective device, not an IVD.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.

Therefore, the Kimberly-Clark KC300 Face Mask is a medical device, but it falls under the category of a protective barrier, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

FXX

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 non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110455, K11402

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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: 678-477-4165
Fax: 920-225-4182 email: monica.king@kcc.com
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
AND PRODUCT
CODE:	Product Code - FXX

1

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
KC300 (K111402) | Predicate Device
(K110455) | KC300 (Proposed
Device) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Kimberly-Clark,
K0200 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. | 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. | 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.

2

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.

3

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.

4

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.

5

· 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

6

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.