The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Arsoft Nitrile Examination Gloves, Non-sterile Powder Free.
| Device ID | K990427 |
| 510k Number | K990427 |
| Device Name: | ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ALLIANCE RUBBER PRODUCTS SDN. BHD. LOT 2716&2720, MK 7, KAWASAN PERINDUSTRIAN BUKIT PANCHOR Nibong Tebal, Pulau Pinang, MY 14300 |
| Contact | Chua Hooi Koon |
| Correspondent | Chua Hooi Koon ALLIANCE RUBBER PRODUCTS SDN. BHD. LOT 2716&2720, MK 7, KAWASAN PERINDUSTRIAN BUKIT PANCHOR 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 | 1999-02-11 |
| Decision Date | 1999-04-23 |