510(k) K962205 ยท KKX Drape, Surgical, Antimicrobial
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Nov 26, 1996 |
| Received | Jun 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962205
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DRAPE PACK, Model Number: DYNJ35363A;
2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005 Open, Classified |
KKX | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ;
2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ;
3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ;
4) PAC Open, Classified |
KKX | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 Open, Classified |
KKX | None listed |
| Nov 13, 2003 | Medline Industries Inc Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486 Terminated |
KKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.