Company · US
Standard Textile Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2024. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2024 | K241214 | ProPel SG3 Surgical Gown Standard Textile Co., Inc. | FYA |
| Aug 25, 2017 | K172207 | Standard Supreme Sterilization Wrapper Standard Textile Co., Inc. | FRG |
| Nov 4, 2016 | K162162 | Barrier Supreme Sterilization Wrapper Standard Textile Co., Inc. | FRG |
| Mar 7, 2006 | K060181 | COMPE1 1 -PLY SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Jul 1, 2005 | K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS Standard Textile Co., Inc. | FYA |
| May 5, 2005 | K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 28, 2005 | K041539 | COMPEL SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Mar 16, 2005 | K041541 | COMPEL MLR SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Dec 3, 2001 | K012268 | TRIMAX Standard Textile Co., Inc. | FYA |
| Oct 11, 2001 | K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES Standard Textile Co., Inc. | KKX |
| Jun 7, 2001 | K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) Standard Textile Co., Inc. | FYA |
| Feb 26, 1998 | K980183 | PROMAX SURGICAL DRAPES AND COVERS Standard Textile Co., Inc. | KKX |
| Apr 27, 1995 | K945371 | COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 25, 1995 | K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) Standard Textile Co., Inc. | FYA |
| Feb 28, 1995 | K944863 | COMPEL SURGICALDRAPES Standard Textile Co., Inc. | KKX |
| Apr 22, 1994 | K940758 | COMPEL SURGICAL GOWNS Standard Textile Co., Inc. | FYA |
| Apr 8, 1993 | K923408 | WRAPPEL T Standard Textile Co., Inc. | FRG |
| Mar 9, 1993 | K922753 | COMPEL XTR Standard Textile Co., Inc. | FYA |
| Feb 23, 1993 | K923811 | COMPEL SURGICAL DRAPES Standard Textile Co., Inc. | KKX |
| Feb 18, 1993 | K921889 | COMPEL O AND R Standard Textile Co., Inc. | FYA |
| Apr 2, 1992 | K914839 | COMPEL E Standard Textile Co., Inc. | FYA |
| Aug 3, 1988 | K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. Standard Textile Co., Inc. | LRO |
| Feb 19, 1986 | K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 Standard Textile Co., Inc. | KKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||