The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Rs Nitrilstst Medical Examination Gloves, Powdered (non Sterile) Blue.
| Device ID | K003233 |
| 510k Number | K003233 |
| Device Name: | RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | RIVERSTONE RESOURCES SDN. BHD. LOT 21909, NO.5, LORONG HELAN HINDIK KEPONG BARU INDUST. EST Kepong Baru, Kuala Lumpur, MY 52100 |
| Contact | Chong Chu Mee |
| Correspondent | Chong Chu Mee RIVERSTONE RESOURCES SDN. BHD. LOT 21909, NO.5, LORONG HELAN HINDIK KEPONG BARU INDUST. EST Kepong Baru, Kuala Lumpur, MY 52100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2000-11-03 |