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I-MED Protective Isolation Gown

I-Med Pharma Inc · Model 5500 · UDI-DI 00622554055000

FME
5
510(k) clearances
8
Adverse events (1 deaths)
1
Recalls
237
Facilities

Description

The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Gowns are manufactured from a premium impervious SMS material base fabric and are available in white and sizes S to 2XL. 100% waterproof efficiency and high-repellency medical-grade protection Ties at back of neck and waist, with elastic wrist or knitted cuff.

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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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.