The following data is part of a premarket notification filed by Pt. Medisafe Technologies with the FDA for Powderfree Polychloroprene Sterilized Surgical Gloves.
| Device ID | K030228 |
| 510k Number | K030228 |
| Device Name: | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra, ID 20153 |
| Contact | Anil Taneja |
| Correspondent | Anil Taneja PT. MEDISAFE TECHNOLOGIES JL. KAPT. PATTIMURA NO. 23 Medan, North Sumatra, ID 20153 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-22 |
| Decision Date | 2003-03-14 |