(162 days)
The 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 non-sterile.
The Surgical face mask is designed and manufactured by Foshan Nanhai Plus Medical CO LTD. It is non-sterile and for single use. The Surgical face mask is a sandwich structure with the inner and outer layer of polypropylene nonwoven. The middle layer is polypropylene melt-blown nonwoven which provides barrier protection to microorganism, body fluid and particulate aerosol transfer. The ear loop is made with polypropylene nonwoven (tie strap type) or spandex elastic (ear loop type). The Surgical face mask is latex free. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The provided document is a 510(k) premarket notification for a Surgical Face Mask. It details the device's technical specifications and comparative performance against a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or associated clinical performance evaluation. Therefore, I cannot provide information on acceptance criteria and study data related to AI/Machine Learning algorithm performance, ground truth establishment, expert adjudication, or MRMC studies.
However, I can extract the acceptance criteria and performance data for the physical properties and biological safety of the surgical face masks as presented in the document.
1. A table of acceptance criteria and the reported device performance for physical properties and biocompatibility:
The document presents performance data for both Level 2 and Level 3 surgical face mask models, as per ASTM F2100-19 standards. The testing was conducted on samples from "3 non-consecutive lots."
Table of Acceptance Criteria and Reported Device Performance (Surgical Face Mask - Physical and Biocompatibility Testing)
| Test Item & Purpose | Acceptance Criteria (Level 2) | Reported Performance (Level 2) | Acceptance Criteria (Level 3) | Reported Performance (Level 3) | Result (Both Levels) |
|---|---|---|---|---|---|
| Performance Test: Flammability | Class 1 (ASTM F2100) | Class 1 | Class 1 (ASTM F2100) | Class 1 | Pass |
| Purpose: Testing the characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion. | |||||
| Performance Test: Bacterial Filtration Efficiency (BFE) | ≥ 98% (ASTM F2100) | Average at 99.66% | ≥ 98% (ASTM F2100) | Average at 99.58% | Pass |
| Purpose: Testing the effectiveness of medical face mask material in preventing the passage of aerosolized bacteria. | |||||
| Performance Test: Differential Pressure (mm H2O/cm²) |
§ 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.