(154 days)
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.
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.
Here's a summary of the acceptance criteria and study information for the KC 200 and KC 300 Face Masks, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All results of testing met acceptance criteria." However, specific numerical acceptance criteria (e.g., "BFE > 95%") are not explicitly listed in the provided text. Instead, meeting the standards themselves serves as the acceptance criterion.
| Test Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ASTM 2100-11 (Medical Face Mask Materials) | Compliance with standard | Met acceptance criteria |
| ASTM F2100-11 (Bacterial Filtration Efficiency - BFE) | Compliance with standard | Met acceptance criteria |
| Mil- M369454C (Military Specifications: Surgical Mask, disposable) | Compliance with standard | Met acceptance criteria |
| PSC CS-191-53 (Flammability Test Method - 16 CFR 1610) | Compliance with standard | Met acceptance criteria |
| ASTM F 2299 (Evaluating Initial Efficiency of Materials to Particulate Penetration) | Compliance with standard | Met acceptance criteria |
| ISO 10993 (Biocompatibility of a Medical Device) | Compliance with standard | Met acceptance criteria |
| ASTM F 1862 (Resistance of Medical Face Masks to Penetration by Synthetic Blood) | Compliance with standard | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each test (e.g., number of masks tested for BFE).
The data provenance is not specified, but it's implied to be from laboratory testing rather than human subject data or clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for these tests is established by fulfilling the objective, standardized criteria of the specified ASTM, Mil, PSC, and ISO test methods, which are laboratory-based performance measurements. No human experts are involved in establishing 'ground truth' in the context of these device performance tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and objective, following established protocols. No adjudication method is described or necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is not relevant for surgical face masks which are evaluated based on their physical and performance characteristics against established standards, not on human interpretation of medical images or data.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (face mask), not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used is based on objective performance measurements against established industry and military standards (ASTM, Mil-Spec, ISO, PSC). These standards define the acceptable physical and filtration characteristics for surgical masks.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not use a training set.
§ 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.