The following data is part of a premarket notification filed by P.t. Irama Dinamika Latex with the FDA for Patient Examination Gloves.
| Device ID | K913776 |
| 510k Number | K913776 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | P.T. IRAMA DINAMIKA LATEX JLN. HANG KESTURI NO.8 Medan - Indonesia, ID |
| Contact | Venkatesan |
| Correspondent | Venkatesan P.T. IRAMA DINAMIKA LATEX JLN. HANG KESTURI NO.8 Medan - Indonesia, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1991-11-07 |