(179 days)
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.
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.
The Kimberly-Clark KC300 Face Mask is a surgical mask that was tested against several ASTM standards and military specifications to ensure its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance:
The device's performance was evaluated against the following criteria, and all reported results met these criteria:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-11) | Meets ASTM F2100-11 standards | Met acceptance criteria |
| Synthetic Blood Penetration Resistance (ASTM F1862-07) | Meets ASTM F2100-11 and ASTM F1862-07 standards | Met acceptance criteria |
| Particulate Filtration Efficiency (PFE) (ASTM F2299-03) | Meets ASTM F2100-11 and ASTM F2299-03 standards | Met acceptance criteria |
| Flammability (16 CFR 1610 (PSC CS-191-53) / Mil-M36954C Military Specifications) | Meets 16 CFR 1610 (PSC CS-191-53) and Mil-M36954C | Met acceptance criteria |
| Biocompatibility (ISO 10993 Standards) | Non-cytotoxic, Non-sensitizing, Non-irritating | Met acceptance criteria |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes used for each test. The tests were performed according to established ASTM standards (ASTM F2100-11, ASTM F1862-07, ASTM F2101-07, ASTM F2299-03), military specifications (MIL-M369454C), and ISO 10993 standards. These are standard laboratory tests for medical devices, implying the data is likely from prospective testing conducted on device samples. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework for FDA submission in the USA.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable. The device is a surgical mask, and its performance is evaluated through objective, standardized laboratory tests rather than through expert review of clinical cases or images.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 consensus are used in studies involving subjective interpretation (e.g., image reading by multiple experts). The performance of a surgical mask is determined by quantifiable physical and biological tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies evaluate human reader performance, often with and without AI assistance, especially in diagnostic imaging. The KC300 Face Mask is a physical device, and its effectiveness is measured through laboratory tests, not human interpretation.
6. Standalone Performance (Algorithm Only):
This section is not applicable. A surgical mask is a physical device, not an algorithm. Therefore, "standalone" performance in the context of algorithms does not apply.
7. Type of Ground Truth Used:
The ground truth for this device is based on objective, standardized laboratory test results that conform to recognized industry standards (ASTM, MIL-SPEC, ISO). These standards define specific measurable criteria for attributes like filtration efficiency, fluid resistance, flammability, and biocompatibility.
8. Sample Size for the Training Set:
This section is not applicable. Surgical masks are physical devices, and their performance is evaluated directly through testing, not through a "training set" in the context of machine learning. The term "training set" is relevant for AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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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: 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 |
|---|---|
| CLASSIFICATIONAND PRODUCTCODE: | 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 DeviceKC300 (K111402) | Predicate Device(K110455) | KC300 (ProposedDevice) |
|---|---|---|---|
| Intended Use | The Kimberly-Clark,K0200 and KC300Face Mask(s) isintended to be wornto protect both thepatient andhealthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulate material.These face masksare intended for usein infection controlpractices to reducethe potentialexposure of thewearer to blood andbody fluids. TheKimberly-Clark,KC200 and KC300face mask(s) is asingle use,disposabledevice(s), providednon-sterile. | The Kimberly-ClarkKC100 Face Mask(s) isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids, andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure ofthe wearer to bloodand body fluids. TheKimberly-Clark KC100face mask(s) is a singleuse, disposabledevice(s), providednon-sterile. | The Kimberly-ClarkKC300 Face Mask isintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms,body fluids andparticulate material.These face masks areintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile.Product Code 47297,KC300 FLUIDSHIELD*Procedure Mask withSO SOFT* LiningProduct Code 47298,KC300 FLUIDSHIELD*Fog-Free ProcedureMask with SO SOFT*LiningProduct Code 48297,KC300 FLUIDSHIELD*Surgical Mask with SOSOFT* Lining |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes | Yes |
| Outer FacingLayer | PolypropyleneSpunbondno print | PolypropyleneSpunbondno print | Polyethylene/Polyester,with pink and blue inkprint |
| Spunbond MiddleLayer | Polypropylenespunbond | N/A (Three layer mask) | Polypropylenespunbond |
| Meltblown MiddleLayer | PolypropyleneMeltblown | PolypropyleneMeltblown | PolypropyleneMeltblown |
| Inner FacingLayer | Polyester cellulose | Polyethylene/Polyester | Polyethylene/Polyester |
| Top and BottomBinding | Polyester Spunlace | Polyester Spunlace | Polyester Spunlace,orPolypropylenespunbond |
| Earloop | Polyester/LycraKnitted | Polyester/Lycra Knitted | Polyester/Lycra Knitted |
| Ties | Polyester Spunlace | Polyester Spunlace | Polypropylenespunbond |
| Kimberly-ClarkBranding | Markem Ink, Blue | Markem Ink, Blue | Markem Ink, Blue |
| Style | Flat-pleated | Flat-pleated | Flat-pleated |
| Offered as fogfree | Yes | Yes | Yes |
| Offered withVisor | Yes | Yes | Yes |
| ProductPerformanceSpecifications | Meets ASTMF2100-11, ASTMF1862-07, ASTMF2101-07, ASTMF2299-03, MIL-M369454C16 CFR 1610 (PSCCS-191-53) | Meets ASTM F2100-11, ASTM F1862-07,ASTM F2101-07,ASTM F2299-03, MIL-M369454C16 CFR 1610 (PSCCS-191-53) | Meets ASTM F2100-11, ASTM F1862-07,ASTM F2101-07,ASTM F2299-03, MIL-M369454C16 CFR 1610 (PSCCS-191-53) |
| Biocompatibility | Biocompatible. Non-cytotoxic, Non-sensitizing, Non-irritating | Biocompatible. Non-cytotoxic, Non-sensitizing, Non-irritating | Biocompatible. Non-cytotoxic, Non-sensitizing, Non-irritating |
| Dimensions-width | 6 5" ± 0.75" | 6 5" ± 0.75" | 6 5" ± 0.75" |
| Dimension-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 (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
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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.
§ 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.