(112 days)
This product is indicated for infection control practices in the health care industry. When worn properly, the Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
The Medical surgical mask is a flat style face mask with ear loops and nose clip for fitting around the nose and mouth. The Medical surgical mask has three layers are made of polypropylene nonwoven and the middle layer is made of polypropylene melt-blown. The outer layer is blue, and the colorant material is identified as Pigment Blue K6911D /CAS number: 12239-87-1. The face mask is held in place over the users' nose and mouth by two polyester and spandex elastic bands as ear loops welded to the face mask. The nose clip is made of iron-cored polypropylene, which allows the users to fit the mask around their nose area.
The dimensions of each mask are 175±5 mm in width. The density of the inner and outer layer is 25 gsm, and the density of the middle layer is 35 gsm. The dimensions of nosepiece are 100±5 mm in length and 3±0.5 mm in width. The ear loop is 175±10 mm in length and 3.5±0.5 mm in width. The Medical surgical mask is sold nonsterile and is intended to be single use, disposable device.
The provided text describes the non-clinical testing performed for the Medical Surgical Mask (Model: KF-B P05(L3)) to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performance | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Bacterial Filtration Efficiency | $\ge 98%$ | 99.65% |
| Differential Pressure (Delta-P) | $ |
§ 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.