standardtextile.comProPel SG3? Surgical Gown
Standard Textile Co., Inc.
STANDARD TEXTILE CO., INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1527185 | 1527185 | STANDARD TEXTILE CO., INC. | 1 | N | 2026-01-01 | 1 Knollcrest Dr Cincinnati OH US 45237 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00634916005523 | Barrier Supreme Wrapper - WRAPPER BARR SUP 35X35 MISTY - MERROWED W/BLUE THREAD W/QCM#2 | 1-800-999-0400 | GUDID@standardtextile.com |
| 00634916070187 | Precaution/Isolation Gown - PRECAUTION GOWN ULTIMATE COMPEL YELLOW XL W/SNAP NK/TTIE @ WAIST | 1-800-999-0400 | GUDID@standardtextile.com |
| 00634916120905 | Instrument Holder - Wrappel Instrument Holder with Pockets, 100% Polyester | 1-800-999-0400 | GUDID@standardtextile.com |
| 00634916349740 | Compel MLR OR Gown - Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER. | 1-800-999-0400 | GUDID@standardtextile.com |
| 00634916781373 | WrapPel Table Cover - WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER' | 1-800-999-0400 | GUDID@standardtextile.com |
| 00634916788358 | ComPel OR Gown - 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body | 1-800-999-0400 | GUDID@standardtextile.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 2937 | 1967602222 | K980183 | PROMAX SURGICAL DRAPES AND COVERS | KKX | 1998-02-26 |
| 2937 | 1824002334 | K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) | FYA | 1995-04-25 |
| 2937 | 1897256887 | K923811 | COMPEL SURGICAL DRAPES | KKX | 1993-02-23 |
| 2937 | 1853327735 | K923408 | WRAPPEL T | FRG | 1993-04-08 |
| 2937 | 1105120865 | K922753 | COMPEL XTR | FYA | 1993-03-09 |
| 2937 | 1249779406 | K921889 | COMPEL O AND R | FYA | 1993-02-18 |
| 2937 | 1212894225 | K241214 | ProPel SG3™ Surgical Gown | FYA | 2024-09-10 |
| 2937 | 1427135033 | K172207 | Standard Supreme Sterilization Wrapper | FRG | 2017-08-25 |
| 2937 | 2066583891 | K162162 | Barrier Supreme Sterilization Wrapper | FRG | 2016-11-04 |
| 2937 | 1013738419 | K041541 | COMPEL MLR SURGICAL GOWNS | FYA | 2005-03-16 |
| 2937 | 1461668527 | K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | FYA | 2005-05-05 |
| 2937 | 1240036947 | K041539 | COMPEL SURGICAL GOWNS | FYA | 2005-04-28 |
| 2937 | 1382461712 | ||||
| 2937 | 1429034384 | ||||
| 2937 | 1495855430 | ||||
| 2937 | 1996502996 | ||||
| 2937 | 2053946361 | ||||
| 2937 | 2068193513 |
Product Codes Associated With Registrations#
PMN#
Standard Supreme Sterilization Wrapper
Standard Textile Co., Inc.
Barrier Supreme Sterilization Wrapper
Standard Textile Co., Inc.
COMPE1 1 -PLY SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS
STANDARD TEXTILE CO., INC.
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
COMPEL SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
COMPEL MLR SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
TRIMAX
Standard Textile Co., Inc.
MODIFICATION TO: COMPEL SURGICAL DRAPES
STANDARD TEXTILE CO., INC.
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
STANDARD TEXTILE CO., INC.
PROMAX SURGICAL DRAPES AND COVERS
STANDARD TEXTILE CO., INC.
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
PERVAL SURGICAL GOWN (MARKETING NAME)
STANDARD TEXTILE CO., INC.
COMPEL SURGICALDRAPES
STANDARD TEXTILE CO., INC.
COMPEL SURGICAL GOWNS
STANDARD TEXTILE CO., INC.
WRAPPEL T
STANDARD TEXTILE CO., INC.
COMPEL XTR
STANDARD TEXTILE CO., INC.
COMPEL SURGICAL DRAPES
STANDARD TEXTILE CO., INC.
COMPEL O AND R
STANDARD TEXTILE CO., INC.
COMPEL E
STANDARD TEXTILE CO., INC.
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
STANDARD TEXTILE CO., INC.
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
STANDARD TEXTILE CO., INC.
GUDID#
ComPel OR Gown - 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
2023-10-10
Barrier Supreme Wrapper - WRAPPER BARR SUP 35X35 MISTY - MERROWED W/BLUE THREAD W/QCM#2
2018-01-29
Precaution/Isolation Gown - PRECAUTION GOWN ULTIMATE COMPEL YELLOW XL W/SNAP NK/TTIE @ WAIST
2018-01-29
Standard Supreme - Instrument Drape, 2 Ply Standard Supreme, 5% COTTON, 45% POLYESTER
2026-03-11
INSTRUMENT COVER - Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester
2026-03-11
Instrument Holder - Wrappel Instrument Holder with Pockets, 100% Polyester
2026-03-11
Compel MLR OR Gown - Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER.
2026-03-11
WrapPel Table Cover - WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER'
2026-03-11
Compel MLR OR Gown - Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
2026-03-11
Compel MLR OR Gown - Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
2026-03-11
Compel MLR OR Gown - Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER
2026-03-11
ProMax Surgical Gown - ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.
2026-03-11
ProMax Surgical Gown, - ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.
2026-03-11
ProMax Surgical Gown, - ProMax Surgical Gown, MLR Front Yoke, 100% POLYESTER.
2026-03-11
OR Gown - 2-Ply Front/Sleeves Aqua Compel MLR
2026-03-11
ComPel Surgical Gown - ComPel Surgical Gown,Ties at Neck and Waist, 100% POLYESTER
2026-03-11
ComPel Surgical Gown - ComPel Surgical Gown, Ties at Neck and Waist, 100% POLYESTER
2026-03-11
ComPel Surgical Gown - ComPel Surgical Gown, Ties at Neck and Waist, 100% POLYESTER.
2026-03-11
Reusable Gown - Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeves.
2026-03-11
Reusable Gown - Reusable Gown, Bound Neck, Neck and Waist Tie Closures, Long Sleeve.
2026-03-11
ComPel Isolation Gown - ComPel Isolation Gown, 100% POLYESTER.
2026-03-11
ProMax Surgical Gown - ProMax Surgical Gown, Front Yoke, 00% POLYESTER.
2026-03-11
Instrument Drape - Instrument Drape, 5% COTTON, 45%POLYESTER.
2026-03-11
ComPel Surgical Gown - ComPel Surgical Gown, Snaps at Neck, Waist, 100% POLYESTER.
2026-03-11
ComPel Surgical Gown, - ComPel Surgical Gown, Neck and Waist Ties, 100% POLYESTER.
2026-03-11
ComPel Surgical Gown - ComPel Surgical Gown, Neck and Waist Ties, 100% POLYESTER
2026-03-11
Circumcision Drape, - Circumcision Drape,Wrappel, Compel/Zorwik, 100% POLYESTER.
2026-03-11
Split Drape - Split Drape with Round Fenestration, 100% POLYESTER.
2026-03-11
T-Lap Fenestrated Drape - T-Lap Fenestrated Drape 100% POLYESTER.
2026-03-11
Reversible Isolation Gown - Reversible Isolation Gown w/ Raglan Sleeves,99% POLYESTER, 1%.
2026-03-11
Reversible Isolation Gown - Reversible Isolation Gown, Raglan Sleeves, 99% POLYESTER, 1%CARBON .
2026-03-11
ProMax Surgical Gown - ProMax Surgical Gown, Front Yoke, 100% POLYESTER.
2026-03-11
Stanguard Drape - Standard Supreme 1-ply Drape Sheet MED 45X90 StanGuard
2018-01-29
Standard Supreme Drape - GOITER SHEET MISTY 72X90 - 1 PLY STD SUPREME HEMMED
2018-01-29
Standard Supreme Drape - ARM SHEETS STANDARD SUPREME 31X60 MISTY - 31X60 2PLY
2018-01-29
Isolation Gown - Isolation Gown, 3 Armhole, AAMI Level 1, Yellow, OSFA, Generic Polyester with Carbon, Wrap Around, Bound Around Neck and Armhole, Long Sleeves with Cuffs
2022-12-12
Standard Supreme Surgical Drape - "DRAPE SUTURE Standard Supreme CEIL 22X22 - W/3"" RND FEN (SR 12966)"
2018-01-29
MAMMOGRAM CAPE - MAMMOGRAPHY CAPE, Century Cloth/Nova Pink 55%cotton/45% Polyester, OSFA
2018-05-21
Barrier Supreme Wrapper - WRAPPER BARR SUP 45X45 JADE - MERROWED W/WHITE THREAD W/QCM2
2018-01-29
Stanguard Drape - MAYO COVER StanGuard - 22 X 52.25 Barrier/Standard Supreme Sugical Drape
2018-01-29