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 |