The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powderfree Black Nitrile Examination Gloves.
| Device ID | K102620 |
| 510k Number | K102620 |
| Device Name: | POWDERFREE BLACK NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA Medan, North Sumatera, ID 20362 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT. MEDISAFE TECHNOLOGIES JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ. MORAWA Medan, North Sumatera, 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 | 2010-09-13 |
| Decision Date | 2010-11-22 |