# Standard Textile Co., Inc.

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 23 (1986–2024): 23 510(k) clearances
- Product codes: FYA (14), KKX (5), FRG (3), LRO (1)
- 510(k) review time since 2016: median 94 days, against 163 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 7 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- George Courey, Inc.: 1 (https://510kreport.com/company/george-courey)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K172207: Standard Supreme Sterilization Wrapper (2017), cited by 2
- K922753: Compel XTR (1993), cited by 2
- K923811: Compel Surgical Drapes (1993), cited by 2
- K923408: Wrappel T (1993), cited by 2
- K921889: Compel O and R (1993), cited by 1

## Recent decisions
- K241214: ProPel SG3™ Surgical Gown (Sep 10, 2024)
- K172207: Standard Supreme Sterilization Wrapper (Aug 25, 2017)
- K162162: Barrier Supreme Sterilization Wrapper (Nov 4, 2016)
- K060181: COMPE1 1 -Ply Surgical Gowns (Mar 7, 2006)
- K041653: Compel 1-Ply Surgical Gowns; Compel Isolation Gowns (Jul 1, 2005)
- K041540: Combosafe (Europe) and Promax (US) Surgical Gowns (May 5, 2005)
- K041539: Compel Surgical Gowns (Apr 28, 2005)
- K041541: Compel MLR Surgical Gowns (Mar 16, 2005)

Source page: https://510kreport.com/company/standard-textile