(25 days)
The Disposable Surgical Face Masks are 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 to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The subject device is a Blue color and Flat Pleated type mask, utilizing the Ear Loops for wearing, and has Nose Piece design for fitting the facemask around the nose. The subject device is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filters. The subject device is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the subject device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of metal core plastic (aluminum metal core inside of polypropylene). The subject device is sold non-sterile and is intended to be single use, disposable device.
The provided document describes the performance of a MIPLNI YK-244 Disposable Surgical Mask based on non-clinical performance testing. It does not contain information about a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device studies cannot be extracted from this document.
However, I can provide the acceptance criteria and reported device performance for the surgical mask.
1. Table of Acceptance Criteria and Reported Device Performance (for the surgical mask):
| Test Item | Standards | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Dimensions | - | Mask Layer: Length: 17.5cm±0.5cm, Width: 9.5cm±0.5cm | Pass |
| Nose Piece: 3mm x 105 mm x 0.5mm | Pass | ||
| Ear loop: 2.8mm in diameter, 195mm in length | Pass | ||
| ASTM F2100 Level | ASTM F2100-19 | Level 3 | Pass |
| Fluid Resistance Performance | ASTM F1862 | 32 out of 32 pass at 160 mmHg | Pass |
| LOT #YKWK20201108: 32/32 at 160 mmHg | |||
| LOT #YKWK20201111: 32/32 at 160 mmHg | |||
| LOT #YKWK20201120: 32/32 at 160 mmHg | |||
| Particulate Filtration Efficiency (PFE) | ASTM F2299 | ≥ 98% | Pass |
| LOT #YKWK20201108: 32/32 99.9% ±0.1% | |||
| LOT #YKWK20201111: 32/32 99.9% ±0.1% | |||
| LOT #YKWK20201120: 32/32 99.9% ±0.1% | |||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101 | ≥ 98% | Pass |
| LOT #YKWK20201108: 32/32 99.9% | |||
| LOT #YKWK20201111: 32/32 99.9% | |||
| LOT #YKWK20201120: 32/32 99.9% | |||
| Differential Pressure (Delta P) | EN 14683:2019+AC:2019 Annex C |
§ 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.