(454 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
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 consist of Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
The provided document is a 510(k) summary for a surgical face mask (K203161), demonstrating substantial equivalence to a predicate device (K202061). This type of regulatory submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and material comparisons. It does not contain information about a study involving human readers or AI assistance. Therefore, I will focus on the performance criteria and the non-clinical studies conducted for this device.
Here's the breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method | Acceptance Criteria | Reported Device Performance (Subject Device - 3 Lots) |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 (Resistance of Surgical face masks to penetration by synthetic blood) | (A) There are no burn times; or (B) There is only one burn time and it is equal to or greater than 3.5 seconds; or (C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. For the purpose of comparison to predicate, the reported criteria is 80 mmHg. | Lot 1: 32 Out of 32 pass at 80 mmHg |
| Lot 2: 32 Out of 32 pass at 80 mmHg | |||
| Lot 3: 32 Out of 32 pass at 80 mmHg | |||
| Particulate Filtration Efficiency (%) | ASTM F2299 (Initial Efficiency of Materials to Penetration by Particulates) | ≥ 95% | Lot 1: Average 96.6% |
| Lot 2: Average 96.1% | |||
| Lot 3: Average 96.2% | |||
| Bacterial Filtration Efficiency (%) | ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE)) | ≥ 95% | Lot 1: Average 99.5% |
| Lot 2: Average 99.4% | |||
| Lot 3: Average 99.4% | |||
| Flammability Class | 16 CFR 1610 (STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES) | Class 1 | Lot 1: Class 1 |
| Lot 2: Class 1 | |||
| Lot 3: Class 1 | |||
| Differential Pressure (Delta-P) (mm H2O/cm²) | ASTM F2100-19 / EN 14683:2019+AC (2019)(E), Annex C (Determine breathing resistance) |
§ 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.