inforMED
QPCClass II

Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

General, Plastic Surgery · 21 CFR 878.4040

A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.

MDR events0All time
Recalls0All time
Registered firms19Currently listed
510(k) clearances10All time

Recent MDR events

0 adverse event reports on file

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No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

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No data available.

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

19 firms currently registered for this product code

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510(k) clearances

10 clearances for this product code

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