The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested For Use With Chemotherapy Drugs.
| Device ID | K182176 |
| 510k Number | K182176 |
| Device Name: | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | PT. Medisafe Technologies JI Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan, ID 20362 |
| Contact | Sajeev Joseph |
| Correspondent | Punitha Samy PT. Medisafe Technologies JI Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar 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 | 2018-08-10 |
| Decision Date | 2019-03-28 |