510(k) K023167 ยท FYA Gown, Surgical
BREATHABLE SURGICAL GOWN
| Applicant | Allegiance Healthcare Corp., Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Oct 2, 2002 |
| Received | Sep 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023167
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large
SKU: 9011 Open, Classified |
FYA | None listed |
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large
SKU: 9041 Open, Classified |
FYA | None listed |
| Nov 2, 2021 | Cardinal Health SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long
SKU: 9041EL Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.