Standard Textile Co., Inc.

FDA Regulatory Profile

Standard Textile Co., Inc. appears in FDA public data with 0 recalls, 23 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on Sep 10, 2024.

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
7
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K241214ProPel SG3™ Surgical GownSep 10, 2024
K172207Standard Supreme Sterilization WrapperAug 25, 2017
K162162Barrier Supreme Sterilization WrapperNov 4, 2016
K060181COMPE1 1 -PLY SURGICAL GOWNSMar 7, 2006
K041653COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSJul 1, 2005
K041540COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNSMay 5, 2005
K041539COMPEL SURGICAL GOWNSApr 28, 2005
K041541COMPEL MLR SURGICAL GOWNSMar 16, 2005
K012268TRIMAXDec 3, 2001
K012807MODIFICATION TO: COMPEL SURGICAL DRAPESOct 11, 2001
K010799COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)Jun 7, 2001
K980183PROMAX SURGICAL DRAPES AND COVERSFeb 26, 1998
K945371COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNSApr 27, 1995
K950504PERVAL SURGICAL GOWN (MARKETING NAME)Apr 25, 1995
K944863COMPEL SURGICALDRAPESFeb 28, 1995
K940758COMPEL SURGICAL GOWNSApr 22, 1994
K923408WRAPPEL TApr 8, 1993
K922753COMPEL XTRMar 9, 1993
K923811COMPEL SURGICAL DRAPESFeb 23, 1993
K921889COMPEL O AND RFeb 18, 1993