Data / Medical devices / United States / Standard Textile Co., Inc.
Standard Textile Co., Inc.: FDA-registered device maker in Cincinnati, OH, United States, 11 510(k) clearances
Standard Textile Co., Inc. is registered with the FDA (registration 1527185) in Cincinnati, OH, United States. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1527185
- Address
- 1 Knollcrest Dr, Cincinnati, OH, United States, 45237
- Owner or operator
- STANDARD TEXTILE CO., INC. (1527185)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- July 7, 1992
- Registered through
- 2026
- Brand names listed
- Atlas, Barrier Supreme Drapes, Barrier Supreme Sterilization Wrapper, CA0 Underpads ATS, CA1 Underpads, CA2 & CA10 Underpads Excel/Comply, CA3 Underpads Truval, CA4 Underpads Integrity and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Mattress (Medical Purposes) | FMW | 1 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Specification developer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Specification developer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Specification developer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2017 | K172207 | Standard Supreme Sterilization Wrapper | FRG | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| November 4, 2016 | K162162 | Barrier Supreme Sterilization Wrapper | FRG | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| May 5, 2005 | K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| April 28, 2005 | K041539 | COMPEL SURGICAL GOWNS | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| March 16, 2005 | K041541 | COMPEL MLR SURGICAL GOWNS | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| February 26, 1998 | K980183 | PROMAX SURGICAL DRAPES AND COVERS | KKX | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| April 25, 1995 | K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| April 8, 1993 | K923408 | WRAPPEL T | FRG | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| March 9, 1993 | K922753 | COMPEL XTR | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| February 23, 1993 | K923811 | COMPEL SURGICAL DRAPES | KKX | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
| February 18, 1993 | K921889 | COMPEL O AND R | FYA | Substantially Equivalent | Standard Textile Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Gown, Surgical
- All makers of Gown, Examination
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Drape, Surgical, Antimicrobial
- All makers of Drape, Surgical, Exempt
Updated August 25, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.