The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs.
| Device ID | K201774 |
| 510k Number | K201774 |
| Device Name: | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential And Tested For Use With Chemotherapy Drugs |
| Classification | Surgeon's Gloves |
| Applicant | PT. Medisafe Technologies J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan, ID 20362 |
| Contact | Sajeev Joseph |
| Correspondent | Punitha Samy PT. Medisafe Technologies J1 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 | 2020-06-29 |
| Decision Date | 2020-09-16 |