510(k) K190950 ยท FYA Gown, Surgical
Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinf
| Applicant | Medline Industries, Inc., Northfiled IL, US |
| Decision | Substantially Equivalent, Jul 4, 2019 |
| Received | Apr 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190950
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP See complete list in RES, exceeds character limit. Medline Surgical Gowns Open, Classified |
FYA | None listed |
| Feb 17, 2026 | Medline Industries, LP Medline Surgical Gowns:
1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001;
2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S;
3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.