(60 days)
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece. These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask but does not involve an AI-powered device or a study comparing AI assistance with human readers. Therefore, the questions related to AI effects, training data, and expert adjudication are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device, "Medical Surgical Mask," was tested according to various standards (ASTM, EN, CFR, ISO). The results are categorized by Level 1 and Level 3 barrier requirements as per ASTM F2100.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | Level 1: 80mmHg | |
| Level 3: 160mmHg | ZKM-U02 (Black) (Level 1): No penetration at 80mmHg | ||
| ZKM-U03 (Blue) (Level 1): 31 out of 32 pass at 80mmHg | |||
| ZKM-U04 (White) (Level 1): 31 out of 32 pass at 80mmHg | |||
| ZKM-U05 (Black) (Level 3): No penetration at 160mmHg | |||
| ZKM-U06 (Blue) (Level 3): 31 out of 32 pass at 160mmHg | |||
| ZKM-U07 (White) (Level 3): 31 out of 32 pass at 160mmHg | |||
| Particulate Filtration Efficiency (ASTM F2299-17) | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | Level 1: ≥95% | |
| Level 3: ≥98% | Pass | ||
| Level 1: ≥96.42% | |||
| Level 3: ≥99.89% | |||
| Bacterial Filtration Efficiency (ASTM F2101-19) | To evaluate the bacterial filtration efficiency (BFE) of the mask. | Level 1: ≥95% | |
| Level 3: ≥98% | Pass | ||
| Level 1: ≥99.6% | |||
| Level 3: ≥99.8% | |||
| Differential Pressure (Delta P) (EN 14683:2019+AC:2019 Annex C) | To measure the differential pressure of mask which is related to breathability. | Level 1: |
§ 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.