The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Ar Safe Nitrile Examination Gloves.
| Device ID | K980589 |
| 510k Number | K980589 |
| Device Name: | AR SAFE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | ALLIANCE RUBBER PRODUCTS SDN. BHD. 878, JALAN BANDAR BARU, SUNGEI KECIL, NIBONG TEBAL Pulau Pinang, MY 14300 |
| Contact | Chua H Koon |
| Correspondent | Chua H Koon ALLIANCE RUBBER PRODUCTS SDN. BHD. 878, JALAN BANDAR BARU, SUNGEI KECIL, NIBONG TEBAL Pulau Pinang, MY 14300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-04-14 |