(73 days)
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is described as a face mask intended for protection and infection control, not for treating any medical condition or disease.
No
The device is a face mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly states it is a physical face mask constructed of nonwoven materials, not software.
Based on the provided information, the Kimberly-Clark KC100 Face Mask is not an IVD (In Vitro Diagnostic) device.
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 test performed on a sample from the human body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
The tests conducted (BFE, flammability, particulate penetration, biocompatibility, synthetic blood penetration) are all related to the physical performance and safety of the mask as a barrier, not its ability to perform a diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
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.
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
healthcare personnel
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)
All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:
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)
1
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, Staphylococcus | |
| Aureus | |
| 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 in |
| Medical 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 by |
| Synthetic 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.
3
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:
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.
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
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