FYBClass II
Gown, Patient
General, Plastic Surgery · 21 CFR 878.4040
MDR events5All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances6All time
Recent MDR events
5 adverse event reports on file
- GOWN, PATIENTOct 6, 2016DeathMedline Industries Inc.1417592-2016-00100
- SRI/SURGICAL EXPRESS, INCJan 6, 2005MalfunctionSri/surgical Express, Inc.2028626-2005-00001
- SRI LIQUID PROOF SURGICAL GOWNFeb 18, 2004MalfunctionSri/surgical Express, Inc.1527607-2004-00001
- CONVERTERS ASTOUNDJul 29, 2003MalfunctionAllegiance/cardinal HealthMW1029156
- CONVERTER GOWNJul 23, 2003MalfunctionAllegiance/cardinal HealthMW1029080
Event type breakdown
Malfunction4
Death1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
6 clearances for this product code
- Liaoning-Usa Corp.May 13, 1991
K911921 · DISPOSABLE ISOLATION GOWN
- Bioshield, Inc.Jul 24, 1989
K891820 · DISPOSABLE MEDICAL GOWNS
- Dispomed, Inc.Apr 12, 1989
K891053 · DENTAL BIB
- Alba Health CareMar 4, 1981
K803171 · PROCEDURE & RECOVERY PATIENT SUIT
- American Convertors Div., American PharmasealJul 28, 1980
K801570 · SHIELD DISP. PATIENTS PONCHO GOWNS
- ConvertorsNov 16, 1977
K771929 · PEDIATRICS GOWN