(100 days)
The Disposable Medical 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 Disposable Medical Masks are single use, three-layer, flat –folded masks with ear strings or ties and nose clip. The two models are exact same except the loop versus tie on design. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven Spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The three layers fabric are held together by ultrasonic welding. The earloops/tie-on ties are held in place over the users' mouth and nose by two strings welded to the facemask. The earloops are made of 19cm spandex and the tie-on ties are made of 90cm spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is not touch with the users' skin directly. The Disposable Medical Masks will be provided in blue. The Disposable Medical Masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) premarket notification for a Disposable Medical Mask (Models: JBHY01, JBHY02). It details non-clinical performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 3 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 3) | Reported Device Performance (Model JBHY01) | Reported Device Performance (Model JBHY02) |
|---|---|---|---|
| Synthetic Blood Performance (ASTM F1862) | 29 out of 32 pass at 160 mmHg | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. | All 3 lots (Lot20200701, Lot20200706, Lot202007014) showed 32 out of 32 pass at 160 mmHg. |
| Particulate Filtration Efficiency (ASTM F2299) | $\geq$ 98% | Lot20200701: Max: 99.48%, Min: 99.93% (Note: Apparent typo, min should be 99.88%, Min: 99.77% | |
| Lot202007014: Max: 99.85%, Min: 99.66% | Lot20200701: Max: 99.83%, Min: 99.59% | ||
| Lot20200706: Max: 99.83%, Min: 99.59% | |||
| Lot202007014: Max: 99.83%, Min: 99.50% | |||
| Differential Pressure (Delta P) (ASTM F2100-19 and EN 14683:2019 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.