Search Results
Found 1 results
510(k) Data Aggregation
(105 days)
Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD
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 |
Ask a specific question about this device
Page 1 of 1