(154 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
The device description and intended use focus on protection and prevention, not on treating a disease or condition in a patient.
No
The device is a face mask intended to protect against transfer of microorganisms and fluids, and its performance studies test filtration efficiency and resistance to penetration, not diagnostic capabilities.
No
The device description clearly states it is a physical face mask constructed of nonwoven materials, with earloops or ties, and a nosepiece. It is a tangible, disposable hardware device.
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 details the physical construction of the mask, materials used, and features like earloops/ties and a nosepiece. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask as a barrier (filtration efficiency, resistance to penetration by blood, flammability) and biocompatibility. These are not diagnostic performance metrics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This face mask does not perform any such function.
N/A
Intended Use / 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.
Product codes
FXX
Device Description
The Kimberly-Clark Face Mask(s) is a four layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester. The mask is provided with earloops or ties in either knitted polyester/lycra or nonwoven polyester. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. Kimberly-Clark KC200 and KC300 Face Mask(s) will be provided with and without a protective visor. Kimberly-Clark 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
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
The KC200 and 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, such as: Mil- M369454C Military Specifications: Surgical Mask, disposable 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. All results of testing met acceptance criteria.
Key Metrics
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.
0
OCT 2 0 2011
510K Summary
| Date Summary was
| Prepared: | May 17, 2011 |
|---|---|
| 510(k) Submitter: | Ann Waterhouse, RAC |
| Associate Director of Regulatory Affairs | |
| Roswell, GA 30076 | |
| 678-352-6719 (telephone) | |
| 920-225-3108 (facsimile) | |
| Ann.waterhouse@kcc.com | |
| Device Trade Name: | KC 200 Face Mask |
| KC 300 Face Mask | |
| Device Common | |
| names | Mask, surgical |
| Device Product | |
| Codes and | |
| Classification | |
| Names: | FXX, Class II |
| 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, |
| constructed of nonwoven polyester blends and pol ypropylene | |
| materials. B indings are nonwoven polyester. The mask is | |
| provided with earloops or ties in either knitted polyester/lycra or | |
| nonwoven polyester. A malleable nosepiece is placed within the | |
| bindings for comfort and individualized fit around the wearer's | |
| nose. Kimberly-Clark KC200 and KC300 Face Mask(s) will be | |
| provided with and w ithout a protective visor. Kimberly-Clark | |
| Face Mask(s) is a single use, disposable device, provided non- | |
| sterile. | |
| Intended Use: | The Kimberly-Clark, KC200 and K C300 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 |
1
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,
disposable 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 |
All results of testing met acceptance criteria.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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