(92 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. This is a single use device, provided non-sterile.
Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow 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 the study results for a medical surgical mask (Model: ZKM-U01). It does not pertain to an AI/ML powered device, therefore, information such as human-in-the-loop performance, effect size of AI assistance, and details about training/test set provenance are not applicable.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg | Yes |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥98% | Pass, average 99.99% | Yes |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | Pass, average > 99.8% | Yes |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) |
§ 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.