The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Rs Orange Nitrile Medical Examination Gloves (powder Free).
| Device ID | K133193 |
| 510k Number | K133193 |
| Device Name: | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | RIVERSTONE RESOURCES SDN. BHD. KAWASAN PERINDUSTRIAN BUKIT BERUNTUNG 48300 BUKIT BERUNTUNG Selangor, MY Malaysia |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar RIVERSTONE RESOURCES SDN. BHD. KAWASAN PERINDUSTRIAN BUKIT BERUNTUNG 48300 BUKIT BERUNTUNG Selangor, MY Malaysia |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-06-23 |
| Summary: | summary |