The following data is part of a premarket notification filed by Pt Delta Waru Rubber Industry with the FDA for Latex Examination Gloves.
| Device ID | K893309 |
| 510k Number | K893309 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT DELTA WARU RUBBER INDUSTRY 2 BRIGJEN KATAMSO ST. WARU/SIDOARJO, 61256 Indonesia, ID |
| Contact | Simon Sion |
| Correspondent | Simon Sion PT DELTA WARU RUBBER INDUSTRY 2 BRIGJEN KATAMSO ST. WARU/SIDOARJO, 61256 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 | 1989-04-18 |
| Decision Date | 1989-07-14 |