(192 days)
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use device, provided non-sterile.
The device is a surgical mask which can be described as non-sterile, single-use, 3 layer, flat-pleated style with ear loops and a nose piece. The outer layer of the surgical mask consists of blue nonwoven spunbond polypropylene and the inner layer consists of carded non-woven polyethylene/polyester. The middle layer consists of melt-blown polypropylene filter. The ear loops consists of 140D nylon and spandex elastic string not made with natural rubber latex. The nose piece is made with white galvanized iron with polyethylene coating.
The provided document is a 510(k) premarket notification for a Surgical Mask. It details the device's characteristics and its comparison to a predicate device, focusing on non-clinical performance data to establish substantial equivalence.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | Fluid resistant, pass at 80 mmHg | Lot K-1820-01: Pass, 29 of 32 Passed at 80 mmHg |
| Lot J-0720-02: Pass, 30 of 32 Passed at 80 mmHg | |||
| Lot J-0920-03: Pass, 29 of 32 Passed at 80 mmHg | |||
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 | ≥95% | Lot J-0620-01: Pass, ≥97.6% |
| Lot J-0720-02: Pass, ≥98.8% | |||
| Lot J-0920-03: Pass, ≥96.8% | |||
| Bacterial Filtration Efficiency | ASTM F2101-01(2019) | ≥95% | Lot J-0620-01: Pass, ≥99.63% |
| Lot J-0720-02: Pass, ≥99.74% | |||
| Lot J-0920-03: Pass, ≥99.57% | |||
| Differential Pressure (Delta-P) | ASTM F2100-19 (EN 14683) |
§ 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.