510(k) K142941 ยท KGO Surgeon'S Gloves
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
| Applicant | Pt. Medisafe Technologies, Tanjung Morawa, Medan, ID |
| Decision | Substantially Equivalent, Nov 2, 2015 |
| Received | Oct 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2026 | Medline Industries, LP Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows:
GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D Open, Classified |
KGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.