The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Latex Patient Examination Gloves.
| Device ID | K896673 |
| 510k Number | K896673 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ALLIANCE RUBBER PRODUCTS SDN. BHD. 4444 JALAN PERMATANG PAUH 13400 BUTTERWORTH, PENANG Malaysia, MY |
| Contact | Hooi Koon |
| Correspondent | Hooi Koon ALLIANCE RUBBER PRODUCTS SDN. BHD. 4444 JALAN PERMATANG PAUH 13400 BUTTERWORTH, PENANG Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-03-08 |