The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powder Free Polychloroprene Examination Gloves-pink With Aloe Vera And Vitamin E.
| Device ID | K163041 |
| 510k Number | K163041 |
| Device Name: | Powder Free Polychloroprene Examination Gloves-Pink With Aloe Vera And Vitamin E |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. MEDISAFE TECHNOLOGIES JI. BATANG KUIS, GG TAMBAK REJO PASAR IX, DESA BUNTU BEDIMBAR Tanjung Morawa, Medan, ID 20362 |
| Contact | Deepak Bang |
| Correspondent | Deepak Bang PT. MEDISAFE TECHNOLOGIES JI. BATANG KUIS, GG TAMBAK REJO PASAR IX, DESA BUNTU BEDIMBAR Tanjung Morawa, Medan, ID 20362 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-02-22 |