The following data is part of a premarket notification filed by Alliance Rubber Products Sdn. Bhd. with the FDA for Nitrile Examination Gloves, Non-sterile, Powdered, Green Color.
| Device ID | K990485 |
| 510k Number | K990485 |
| Device Name: | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | ALLIANCE RUBBER PRODUCTS SDN. BHD. PERINDUSTRIAN BUKIT PANCHOR 14300 NIBONG TEBAL Pulau Pinang, MY 52446-u |
| Contact | Chua Hooi Koon |
| Correspondent | Chua Hooi Koon ALLIANCE RUBBER PRODUCTS SDN. BHD. PERINDUSTRIAN BUKIT PANCHOR 14300 NIBONG TEBAL Pulau Pinang, MY 52446-u |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-04-23 |