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Medical Face Mask

Hans Hepp GmbH & Co. KG · Model 89114 · UDI-DI 04007418891141

QKR

510(k) clearances

225

Adverse events

Recalls

270

Facilities

Description

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Recalls

Date	Firm	Reason
2020-07-21	BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA	Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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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.