Standard Textile Co., Inc.
Cincinnati, OH, US
STANDARD TEXTILE CO., INC. appears in FDA device records in Cincinnati, OH. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Standard Textile Co., Inc. between 1986 and 2024. The busiest year on record is 1993, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1988 | 1 |
| 1992 | 1 |
| 1993 | 4 |
| 1994 | 1 |
| 1995 | 3 |
| 1998 | 1 |
| 2001 | 3 |
| 2005 | 4 |
| 2006 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241214 | ProPel SG3™ Surgical Gown | FYA | Substantially Equivalent | |
| K172207 | Standard Supreme Sterilization Wrapper | FRG | Substantially Equivalent | |
| K162162 | Barrier Supreme Sterilization Wrapper | FRG | Substantially Equivalent | |
| K060181 | COMPE1 1 -PLY SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS | FYA | Substantially Equivalent | |
| K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K041539 | COMPEL SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K041541 | COMPEL MLR SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K012268 | TRIMAX | FYA | Substantially Equivalent | |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) | FYA | Substantially Equivalent | |
| K980183 | PROMAX SURGICAL DRAPES AND COVERS | KKX | Substantially Equivalent | |
| K945371 | COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) | FYA | Substantially Equivalent | |
| K944863 | COMPEL SURGICALDRAPES | KKX | Substantially Equivalent | |
| K940758 | COMPEL SURGICAL GOWNS | FYA | Substantially Equivalent | |
| K923408 | WRAPPEL T | FRG | Substantially Equivalent | |
| K922753 | COMPEL XTR | FYA | Substantially Equivalent | |
| K923811 | COMPEL SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K921889 | COMPEL O AND R | FYA | Substantially Equivalent | |
| K914839 | COMPEL E | FYA | Substantially Equivalent | |
| K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. | LRO | Substantially Equivalent | |
| K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 | KKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1527185 | 1527185 | STANDARD TEXTILE CO., INC. | 1 Knollcrest Dr, Cincinnati, OH 45237 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain