The following data is part of a premarket notification filed by Pt Medisafe Technologies with the FDA for Polychloroprene Powder-free Surgical Glove (white) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (green) Tested For Use With Chemotherapy Drugs.
| Device ID | K142190 |
| 510k Number | K142190 |
| Device Name: | Polychloroprene Powder-free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | PT MEDISAFE TECHNOLOGIES JI BANTANG KUIS. GG TAMBAK REJO PASAR IX, DESA BUNTU BEDIMAR Tanjung Morawa, Medan, ID 20362 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT MEDISAFE TECHNOLOGIES JI BANTANG KUIS. GG TAMBAK REJO PASAR IX, DESA BUNTU BEDIMAR Tanjung Morawa, Medan, ID 20362 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2015-07-14 |