(105 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. They are in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron bar coated with Polyolefin. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices. The proposed device will be provided in two models of level 3. The two models are totally the same, only distinguished by level 2 & level 3 for business purpose.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the "Surgical Face Mask":
Device Name: Surgical Face Mask (Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD)
Regulatory Class: Class II
Product Code: FXX
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 2 & 3) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance | Evaluate resistance to penetration by synthetic blood (Minimum pressure in mmHg) | Level 2: 29 out of 32 pass at 120 mmHg | |
| Level 3: 29 out of 32 pass at 160 mmHg | PASS: 32 out of 32 pass at 160 mmHg (for both Level 2 & 3 models) | ||
| Particulate Filtration Efficiency (PFE) | Evaluate sub-micron particulate filtration efficiency at 0.1 micron (%) | ≥ 98% | PASS: 98.7%; 98.72%; 99.28% |
| Bacterial Filtration Efficiency (BFE) | Evaluate bacterial filtration efficiency (%) | ≥ 98% | PASS: 99.88%; 99.89%; 99.83% |
| Differential Pressure (Delta-P) | Evaluate breathability/resistance to airflow |
§ 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.