The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Alliance Rubber, Ec-grip.
| Device ID | K972801 |
| 510k Number | K972801 |
| Device Name: | ALLIANCE RUBBER, EC-GRIP |
| Classification | Latex Patient Examination Glove |
| Applicant | ALLIANCE RUBBER PRODUCTS SDN. BHD. 878, JALAN BANDAR BARU, SUNGEI KECIL, NIBONG TEBAL Pulau Pinang, MY 14300 |
| Contact | Chua Hooi Koon |
| Correspondent | Chua Hooi Koon ALLIANCE RUBBER PRODUCTS SDN. BHD. 878, JALAN BANDAR BARU, SUNGEI KECIL, NIBONG TEBAL Pulau Pinang, MY 14300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-10-21 |