(172 days)
Not Found
No
The device description and performance studies focus on material properties and standard mask testing, with no mention of AI or ML.
No
The device is a face mask intended to provide protection for the respiratory tract, which is a prophylactic or protective function, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is a facemask intended for protection of the respiratory tract, not for diagnosing any condition.
No
The device description clearly states it is a physical facemask constructed of nonwoven materials, bindings, earloops, 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 is to be worn by a patient/child to provide protection for the respiratory tract. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description details the physical construction and materials of a face mask. It does not describe any components or processes related to analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies mentioned relate to physical properties and standards for face masks (filtration, breathability, etc.), not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This face mask's function is purely protective.
N/A
Intended Use / Indications for Use
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
Product codes
OXZ
Device Description
The Kimberly-Clark Pediatric/ Child Facemask is a three layer mask, constructed of nonwoven polyester blends and polypropylene materials. Bindings are nonwoven polyester and earloops are knitted polyester/lycra. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. The Pediatric/ Child Facemask is appropriately sized to the smaller faces of children across a diverse population. The Pediatric/ Child Facemask 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
respiratory tract
Indicated Patient Age Range
4-12
Intended User / Care Setting
healthcare setting with appropriate adult supervision
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 Kimberly-Clark Pediatric/Children's face mask has been tested under the following standards: 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), ASTM 2101-07 (Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials. Using a Biological Aerosol of Staphylococcus aureus), ISO 10993 (Standards for evaluating the biocompatibility of a medical device). All results of testing 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.
0
.
Kimberly-Clark* Corporation rtimberly Olare Octoberly-Clark* Pediatric/Clark* Pediatric/Child Face Mask
| 510K Summary | ||
|---|---|---|
| Date Summary was | ||
| Prepared: | November 3, 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: | Kimberly-Clark Pediatric/Child Facemask | |
| Device Common | ||
| names | Mask, surgical | |
| Device Product | ||
| Codes and | ||
| Classification | ||
| Names: | OXZ, Class II | |
| Mask, surgical (21 CFR 878.4040) | ||
| Predicate Devices | The Kimberly-Clark Pediatric/Child face mask(s) K103150. | |
| Device Description: | The Kimberly-Clark Pediatric/ Child Facemask is a three layer | |
| mask, constructed of nonwoven polyester blends and | ||
| polypropylene materials. Bindings are nonwoven polyester and | ||
| earloops are knitted polyester/lycra. A malleable nosepiece is | ||
| placed within the bindings for comfort and individualized fit | ||
| around the wearer's nose. The Pediatric/ Child Facemask is | ||
| appropriately sized to the smaller faces of children across a | ||
| diverse population. The Pediatric/ Child Facemask is a single | ||
| use, disposable device, provided non-sterile. | ||
| Intended Use: | The Kimberly-Clark Pediatric/ Child Facemask, is intended to be | |
| worn by the patient/child (recommended ages 4-12) to provide | ||
| protection for the respiratory tract. It is a single use, disposable | ||
| device that is provided non-sterile. This Face Mask is | ||
| recommended for use in a healthcare setting with appropriate |
adult supervision.
MAY - 4 2012 .
1
Kimberly-Clark* Corporation
510(k) for the expansion of age range: Kimberly-Clark* Pediatric/Child Face Mask
| Technological
Characteristics and
Substantial
Equivalence: | The Kimberly-Clark Pediatric/Child face mask is substantially
equivalent to the predicate device, Kimberly-Clark
Pediatric/Child face mask K103150 in intended use and
principles of operation. |
| --------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Summary of Testing:
.
The Kimberly-Clark Pediatric/Children's face mask has been tested under the following standards
| 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 | |
| ASTM 2101-07 | Test Method for Evaluating the Bacterial |
| Filtration Efficiency (BFE) of Medical Face | |
| Mask Materials. Using a Biological Aerosol of | |
| Staphylococcus aureus | |
| ISO 10993 | Standards for evaluating the biocompatibility of |
| a medical device |
All results of testing met acceptance criteria.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ann Waterhouse Associate Director of Regulatory Affairs Kimberly-Clark 1400 Holcomb Bridge Road Roswell, Georgia 30076
MAY - 4 2012
Re: K113340
Trade/Device Name: Kimberly-Clark Pediatric/Child Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: OXZ Dated: April 26, 2012 Received: April 27, 2012
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 Eederal 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 /ucm 115809.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 vours.
Th for
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
Kimberly-Clark* Corporation 510(k) for the expansion of age range: Kimberly-Clark* Pediatric/Child Face Mask
Indications for Use
510(k) Number (if known):
Kimberly-Clark Pediatric/Child Face Mask Device Name:
Indications for Use:
The Kimberly-Clark Pediatric/ Child Facemask, is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
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)
Elizabeth B. Clausing-Wells
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________