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AMERICANA DISPOSABLE FACE MASK

WAKAMONO CORPORATION · Model 1 · UDI-DI 08936081250237

QKR
0
510(k) clearances
225
Adverse events
1
Recalls
269
Facilities

Description

Non-fiberglass, non-irritation, non-carcinogen (formaldehyde) Waterproof, airy, non-irritating fabrics Easily adjusted nose clip helps fixed and best fit to face Reliable and elastic earloops for comfortable use.

Recalls

DateFirmReason
2020-07-21BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIADisposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.