The following data is part of a premarket notification filed by P.t. Intan Hevea Industry with the FDA for Patient Examination Gloves.
| Device ID | K894480 |
| 510k Number | K894480 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | P.T. INTAN HEVEA INDUSTRY JL. K.L. YOS SUDARSO K.M. 9.5 (KP. MABAR) Medan - Indonesia, ID |
| Contact | Mansur Tandjo |
| Correspondent | Mansur Tandjo P.T. INTAN HEVEA INDUSTRY JL. K.L. YOS SUDARSO K.M. 9.5 (KP. MABAR) 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 | 1989-07-18 |
| Decision Date | 1989-09-15 |