The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Rs Safe Blue Nitrile Medical Examination Gloves (powder Free).
| Device ID | K100603 |
| 510k Number | K100603 |
| Device Name: | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | RIVERSTONE RESOURCES SDN. BHD. JALAN JASMIN 2 48300 BUKIT BERUNTUNG Selangor, MY 48300 |
| Contact | Chong Chu Mee |
| Correspondent | Chong Chu Mee RIVERSTONE RESOURCES SDN. BHD. JALAN JASMIN 2 48300 BUKIT BERUNTUNG Selangor, MY 48300 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-07-16 |
| Summary: | summary |