FDA 510(k) Applications Submitted by Standard Textile Co., Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K010799 |
03/16/2001 |
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) |
STANDARD TEXTILE CO., INC. |
| K980183 |
01/20/1998 |
PROMAX SURGICAL DRAPES AND COVERS |
STANDARD TEXTILE CO., INC. |
| K060181 |
01/23/2006 |
COMPE1 1 -PLY SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
| K041539 |
06/08/2004 |
COMPEL SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
| K041540 |
06/08/2004 |
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
| K041541 |
06/08/2004 |
COMPEL MLR SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
| K041653 |
06/17/2004 |
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS |
STANDARD TEXTILE CO., INC. |
| K012268 |
07/19/2001 |
TRIMAX |
STANDARD TEXTILE CO., INC. |
| K012807 |
08/22/2001 |
MODIFICATION TO: COMPEL SURGICAL DRAPES |
STANDARD TEXTILE CO., INC. |
| K172207 |
07/21/2017 |
Standard Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
| K162162 |
08/02/2016 |
Barrier Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
| K241214 |
04/30/2024 |
ProPel SG3Ö Surgical Gown |
Standard Textile Co., Inc. |
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