510(k) K964142 ยท KKX Drape, Surgical, Antimicrobial
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
| Applicant | Medline Industries, Inc., Mundelein IL, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Oct 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964142
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2018 | Arrow International Inc Maximal Barrier Drape; Product Codes: ASK-00001-1A Terminated |
KKX | None listed |
| Apr 11, 2018 | Arrow International Inc Clear Fenestrated Drape with Adhesive; Product Code: CD-00001 Terminated |
KKX | None listed |
| Jun 1, 2017 | Master & Frank (Pinghu) Co., Ltd. MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns. Open, Classified |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.