(36 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 provided nonsterile.
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with a nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.
The provided text is for a 510(k) summary for a "Surgical Mask" and details a series of non-clinical (benchtop) performance tests and biocompatibility tests. It does not describe a study involving human readers or AI assistance. Therefore, some of the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, and expert qualifications is not applicable.
Here's the breakdown of the acceptance criteria and performance data for the Surgical Mask:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Benchtop Performance Testing | |||
| Resistance to Penetration by Synthetic Blood (ASTM F1862) | To demonstrate the Resistance to Penetration by Synthetic Blood ASTM F1862 of the subject device. | 29 out of 32 pass at 160 mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg. |
| Lot 1: 32/32 passed. | |||
| Lot 2: 32/32 passed. | |||
| Lot 3: 32/32 passed. | |||
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the Particulate Filtration Efficiency ASTM F2299 of the subject device. | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. |
| Lot 1: 32/32 passed. | |||
| Lot 2: 32/32 passed. | |||
| Lot 3: 32/32 passed. | |||
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the Bacterial Filtration Efficiency ASTM F2101 of the subject device. | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%. |
| Lot 1: 32/32 passed. | |||
| Lot 2: 32/32 passed. | |||
| Lot 3: 32/32 passed. | |||
| Differential Pressure (EN 14683:2019) | To demonstrate the Differential Pressure EN 14683:2019 of the subject device. |
§ 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.