FYEClass I

Dress, Surgical

General, Plastic Surgery · 21 CFR 878.4040

MDR events12All time

Recalls1All time

Registered firms121Currently listed

510(k) clearances7All time

Recent MDR events

12 adverse event reports on file

BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, XLJan 14, 2005
OtherMolnlycke Health Care, Ab2523357-2005-00001
BARRIER EXTRA PROTECTION SURGICAL GOWN, LGNov 7, 2003
OtherMolnlycke Health Care Ab2523357-2003-00008
BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGEOct 30, 2003
OtherMolnlycke Health Care Ab2523357-2003-00007
BARRIER EXTRA PROTECTION SURGICAL GOWN, EXTRA LARGEAug 29, 2003
OtherMolnlycke Health Care Ab2523357-2003-00006
BARRIER EXTRA PROTECTION PLUS GOWN, LARGEMay 21, 2003
OtherMolnlycke Health Care, Inc.2523357-2003-00003
BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, EXTRA LARGEMay 21, 2003
OtherMolnlycke Health Care, Inc.2523357-2003-00004
BARRIER EXTRA PROTECTION PLUS GOWN, EXTRA LARGEMay 21, 2003
OtherMolnlycke Health Care, Inc.2523357-2003-00005
BARRIER EXTRA PROTECTION PLUS SURGICAL GOWN, LARGEMay 21, 2003
OtherMolnlycke Health Care, Inc.2523357-2003-00002
BARRIER EXTRA PROTECTION PLUS GOWN, LARGEMay 21, 2003
OtherMolnlycke Health Care, Inc.2523357-2003-00001
BARRIER BRAND ULTRA PROTECTION SURGICAL GOWN, LARGEAug 9, 2002
OtherMolnlycke Health Care, Inc.2523357-2002-00003

Event type breakdown

Other12

Most-reported manufacturers

Molnlycke Health Care, Inc.8 Molnlycke Health Care Ab3 Molnlycke Health Care, Ab1

Recalls

1 recall events for this product code

DePuy Orthopaedics, Inc.
TerminatedMay 16, 2013
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg
LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.
Z-1331-2013 · View FDA record ↗

Registered firms

121 firms currently registered for this product code

510(k) clearances

7 clearances for this product code