The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powderfree Polyisoprene Surgical Gloves.
| Device ID | K112654 |
| 510k Number | K112654 |
| Device Name: | POWDERFREE POLYISOPRENE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2012-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30686864060063 | K112654 | 000 |
| 30686864059876 | K112654 | 000 |
| 30686864059883 | K112654 | 000 |
| 30686864059890 | K112654 | 000 |
| 30686864059906 | K112654 | 000 |
| 30686864060025 | K112654 | 000 |
| 30686864060032 | K112654 | 000 |
| 30686864060049 | K112654 | 000 |
| 30686864060056 | K112654 | 000 |
| 30686864059869 | K112654 | 000 |