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VINMASK

NHAT QUANG INDUSTRY COOPERATIVE · Model 1 · UDI-DI 00860004057208

MSH
10
510(k) clearances
195
Adverse events
3
Recalls
226
Facilities

Description

A form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Recalls

DateFirmReason
2023-08-09O&M HALYARD, INC.One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
2008-07-23Inovel LLCDisplay boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
2006-02-20Inovel LLCMislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect mod

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.