(73 days)
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 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.
The acceptance criteria and study proving K110455 device meets those criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Standard | Title | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mil-M369454C | Military Specifications: Surgical Mask, disposable 1992 | Not explicitly stated as an acceptance criterion in the provided text, but implies compliance with military specifications for surgical masks. | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." This statement broadly covers compliance with this standard. |
| ASTM F2101-07 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol, Staphylococcus Aureus | Not explicitly stated in the provided text, but generally, acceptance criteria for BFE are a minimum percentage (e.g., ≥ 95% or ≥ 98%) depending on the mask type. | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| PSC CS-191-53 | Flammability Test Method (16 CFR 1610) for Flammability of Clothing Textiles | Not explicitly stated in the provided text, but relates to flammability resistance (e.g., Class 1 for fabrics). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| ASTM F2299 | Standard Test Method for Evaluating the Initial Efficiency of Materials Used in Medical Masks to Penetration of Particulates Using Latex Spheres | Not explicitly stated in the provided text, but generally involves a minimum particle filtration efficiency (e.g., ≥ 95% for 0.1 µm particles). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| ISO 10993 | Standards for evaluating the biocompatibility of a medical device | Not explicitly stated in the provided text, but implies the device passed various biocompatibility tests (e.g., cytotoxicity, irritation, sensitization). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
| F 1862 | Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Not explicitly stated in the provided text, but would typically involve a specific level of resistance to synthetic blood penetration (e.g., passing at a certain pressure). | "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria." |
Note: While the document states "All testing conducted on the Kimberly-Clark KC100 Procedure Mask(s) met acceptance criteria," the specific quantitative acceptance criteria for each standard are not explicitly detailed in the provided text. These would typically be defined within the test protocols for each standard.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for the test set for each of the listed standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). Safety and performance testing of medical devices like masks is typically performed prospectively, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and testing. The "ground truth" for mask performance testing is established by objective measurements against standardized test methods (e.g., measuring BFE with a particle counter, resistance to blood penetration under specific pressure). It does not involve expert consensus on visual interpretations or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation of mask performance is based on objective, standardized tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (surgical mask) and its performance based on laboratory testing, not human-AI interaction for interpretation.
6. Standalone Performance Study
This document describes standalone performance testing for the physical device itself (Kimberly-Clark KC100 Face Masks). The tests performed (BFE, particle filtration, flammability, synthetic blood penetration, biocompatibility) are all designed to evaluate the mask's inherent protective properties and material characteristics in a laboratory setting, without human interaction. Therefore, a standalone performance study was done for the device.
7. Type of Ground Truth Used
The ground truth used for these studies is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., BFE measured by specific equipment, particle penetration quantified by particle counters, flammability determined by burn rates, synthetic blood penetration by visual inspection at defined pressures, biocompatibility by cellular responses). It is not based on expert consensus, pathology, or outcomes data in the typical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm requiring a training set. The performance is assessed through laboratory testing of physical samples.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical device.
§ 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.