(56 days)
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
Acceptance Criteria and Device Performance for 3 Layer Surgical Mask
The provided document describes the acceptance criteria and the study that proves the device, a "3 Layer Surgical Mask," meets these criteria. The study focuses on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, K202595).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F 1862) | Evaluate resistance to penetration by synthetic blood (2ml high velocity stream). | 29 out of 32 pass at 120 mmHg | Lot 1: 32 out of 32 pass at 160 mmHg | |
| Lot 2: 32 out of 32 pass at 160 mmHg | ||||
| Lot 3: 31 out of 32 pass at 160 mmHg | PASS | |||
| Particulate Filtration Efficiency (ASTM F 2299) | Measure initial particle filtration efficiency using monodispersed aerosols (0.1 um latex spheres). | ≥ 98% PFE | Lot 1: 99.80% | |
| Lot 2: 99.83% | ||||
| Lot 3: 99.87% | PASS | |||
| Bacterial Filtration Efficiency (ASTM F 2101) | Measure Bacterial Filtration Efficiency using a biological aerosol of Staphylococcus Aureus. | > 98% BFE | Lot 1: 99.8% | |
| Lot 2: 99.8% | ||||
| Lot 3: 99.8% | PASS | |||
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1, Normal Flammability | Lot 1: DNI (Did Not Ignite) | |
| Lot 2: DNI | ||||
| Lot 3: DNI | ||||
| All 3 Lots met Class 1 Flammability standards | PASS | |||
| Differential Pressure (EN 14683:2019+AC:2019) | Determine overall breathability through the mask barrier. | 29/32 pass at 120 mmHg. |
* **Filtration Efficiency (PFE & BFE):** ≥ 98%.
* **Flammability:** Class 1.
* **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.