(208 days)
The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable 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(s), provided sterile.
The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable 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(s), provided sterile.
The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric.
The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex.
The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire.
The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.
The provided document is a 510(k) Summary for a medical device, a "Disposable Medical Surgical Mask". It details the device's technical characteristics, performance, and biocompatibility compared to a predicate device, as well as the non-clinical tests performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (Table 2 and Test Method/Results table, page 7) |
| ASTM F2299 | Sub-micron particulate filtration efficiency at 0.1 micron | ≥ 98% | ≥ 98% (Table 2 and Test Method/Results table, page 7) |
| ASTM F2101 | Bacterial Filtration Efficiency | ≥ 98% | ≥ 99% (Table 2 and Test Method/Results table, page 7) |
| EN 14683 Annex C | Differential Pressure |
§ 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.