510(k) K182172 ยท FYA Gown, Surgical
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
| Applicant | Medline Industries, Inc., Northfiled IL, US |
| Decision | Substantially Equivalent, Apr 24, 2019 |
| Received | Aug 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile. Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.