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Isolation Gown
STANDARD TEXTILE CO., INC. · Model 666Y4815 · UDI-DI 00634916792591
0
510(k) clearances
49
Adverse events
18
Recalls
563
Facilities
Description
Isolation Gown, AAMI Level 1, Yellow, Large, Generic Polyester, Bound Neck, Neck and Waist Tie Closures, Extended Ties at Waist, Long Sleeves with White Cuffs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | New York Embroidery Studio, Inc. | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.