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510(k) Data Aggregation
(78 days)
Motex Anti-Fog Surgical Face Mask
The Motex Anti-Fog Surgical Face Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop, is flat pleated 3-ply device, which consists of four layers, i.e., Inner layer (Bicomponent thermal-bonded nonwoven, Polypropylene / Polyethylene, PP/PE), Filter layer (Polypropylene Melt-blown), Outer layer (Polypropylene Spunbond, blue/ green/ white/ pink color) and Anti-Fog films (EP coated Polyethylene). Each mask contains tie-on strips or elastic ear loops and of steel wire coated with Polyethylene resin to secure the mask fit over the user's mouth and nose. The dimensions of each mask are length 165±5 mm and width 95±2 mm.
The provided text describes the acceptance criteria and performance data for the Motex Anti-Fog Surgical Face Mask.
1. A table of acceptance criteria and the reported device performance
| Test item (Performance Level 3) | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Bacterial filtration efficiency | ≥ 98% | ≥99% | Pass |
| Differential pressure (Delta-P) |
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