Medical Device Manufacturer · US , Cincinnati , OH

Standard Textile Co., Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1986
Official Website
23
Total
23
Cleared
0
Denied

Standard Textile Co., Inc. has 23 FDA 510(k) cleared general hospital devices. Based in Cincinnati, US.

Latest FDA clearance: Sep 2024. Active since 1986.

Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by RQM+ as regulatory consultant.

FDA 510(k) Regulatory Record - Standard Textile Co., Inc.

23 devices
1-23 of 23
Cleared Sep 10, 2024
ProPel SG3™ Surgical Gown
K241214 · FYA
General Hospital · 133d
Cleared Aug 25, 2017
Standard Supreme Sterilization Wrapper
K172207 · FRG
General Hospital · 35d
Cleared Nov 04, 2016
Barrier Supreme Sterilization Wrapper
K162162 · FRG
General Hospital · 94d
Cleared Mar 07, 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · FYA
General Hospital · 43d
Cleared Jul 01, 2005
COMPEL 1-PLY SURGICAL GOWNS
K041653 · FYA
General Hospital · 379d
Cleared May 05, 2005
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · FYA
General Hospital · 331d
Cleared Apr 28, 2005
COMPEL SURGICAL GOWNS
K041539 · FYA
General Hospital · 324d
Cleared Mar 16, 2005
COMPEL MLR SURGICAL GOWNS
K041541 · FYA
General Hospital · 281d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
General Hospital · 137d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · KKX
General Hospital · 50d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · FYA
General Hospital · 83d
Cleared Feb 26, 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · KKX
General Hospital · 37d
Cleared Apr 27, 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · FYA
General Hospital · 176d
Cleared Apr 25, 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · FYA
General Hospital · 78d
Cleared Feb 28, 1995
COMPEL SURGICALDRAPES
K944863 · KKX
General Hospital · 148d
Cleared Apr 22, 1994
COMPEL SURGICAL GOWNS
K940758 · FYA
General Hospital · 63d
Cleared Apr 08, 1993
WRAPPEL T
K923408 · FRG
General Hospital · 272d
Cleared Mar 09, 1993
COMPEL XTR
K922753 · FYA
General Hospital · 274d
Cleared Feb 23, 1993
COMPEL SURGICAL DRAPES
K923811 · KKX
General Hospital · 209d
Cleared Feb 18, 1993
COMPEL O AND R
K921889 · FYA
General Hospital · 302d
Cleared Apr 02, 1992
COMPEL E
K914839 · FYA
General Hospital · 160d
Cleared Aug 03, 1988
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · LRO
General & Plastic Surgery · 34d
Cleared Feb 19, 1986
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · KKX
General Hospital · 15d
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