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Standard Textile Co., Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
6
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K241214ProPel SG3™ Surgical GownSeptember 10, 2024
K172207Standard Supreme Sterilization WrapperAugust 25, 2017
K162162Barrier Supreme Sterilization WrapperNovember 4, 2016
K060181COMPE1 1 -PLY SURGICAL GOWNSMarch 7, 2006
K041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSJuly 1, 2005
K041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNSMay 5, 2005
K041539COMPEL SURGICAL GOWNSApril 28, 2005
K041541COMPEL MLR SURGICAL GOWNSMarch 16, 2005
K012268TRIMAXDecember 3, 2001
K012807MODIFICATION TO: COMPEL SURGICAL DRAPESOctober 11, 2001
K010799COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)June 7, 2001
K980183PROMAX SURGICAL DRAPES AND COVERSFebruary 26, 1998
K945371COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNSApril 27, 1995
K950504PERVAL SURGICAL GOWN (MARKETING NAME)April 25, 1995
K944863COMPEL SURGICALDRAPESFebruary 28, 1995
K940758COMPEL SURGICAL GOWNSApril 22, 1994
K923408WRAPPEL TApril 8, 1993
K922753COMPEL XTRMarch 9, 1993
K923811COMPEL SURGICAL DRAPESFebruary 23, 1993
K921889COMPEL O AND RFebruary 18, 1993