Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Standard Textile with 23 510(k) clearances. The most recent is a 510(k) clearance dated Sep 10, 2024: ProPel SG3™ Surgical Gown.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 10, 2024 | ProPel SG3™ Surgical GownK241214 · FYA | 510(k) clearances |
| Aug 25, 2017 | Standard Supreme Sterilization WrapperK172207 · FRG | 510(k) clearances |
| Nov 4, 2016 | Barrier Supreme Sterilization WrapperK162162 · FRG | 510(k) clearances |
| Mar 7, 2006 | COMPE1 1 -PLY SURGICAL GOWNSK060181 · FYA | 510(k) clearances |
| Jul 1, 2005 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNSK041653 · FYA | 510(k) clearances |
| May 5, 2005 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNSK041540 · FYA | 510(k) clearances |
| Apr 28, 2005 | COMPEL SURGICAL GOWNSK041539 · FYA | 510(k) clearances |
| Mar 16, 2005 | COMPEL MLR SURGICAL GOWNSK041541 · FYA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
