The following data is part of a premarket notification filed by Pt. Irama Dinamika Latex with the FDA for Chloroprene Exam Gloves.
| Device ID | K963771 |
| 510k Number | K963771 |
| Device Name: | CHLOROPRENE EXAM GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. IRAMA DINAMIKA LATEX JL. KAPTEN PATTIMURA NO. 23/ 235 MEDAN 21053 Indonesia, ID |
| Contact | Anil Tanelja |
| Correspondent | Anil Tanelja PT. IRAMA DINAMIKA LATEX JL. KAPTEN PATTIMURA NO. 23/ 235 MEDAN 21053 Indonesia, ID |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-19 |
| Decision Date | 1996-12-19 |