The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Nitrile Patient Examination Gloves, Powdered, Non-sterile.
| Device ID | K992558 |
| 510k Number | K992558 |
| Device Name: | NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE |
| 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 | C.m. Chong |
| Correspondent | C.m. Chong 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 | 1999-07-30 |
| Decision Date | 1999-09-27 |