The following data is part of a premarket notification filed by Riverstone Resources Sdn. Bhd. with the FDA for Rs Care Latex Medical Examination Glove (powder Free).
| Device ID | K100611 |
| 510k Number | K100611 |
| Device Name: | RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | RIVERSTONE RESOURCES SDN. BHD. KAWASAN PERINDUSTRIAN BUKIT 48300 BUKIT BERUNTUNG Selangor, MY |
| Contact | Chong Chu Mee |
| Correspondent | Chong Chu Mee RIVERSTONE RESOURCES SDN. BHD. KAWASAN PERINDUSTRIAN BUKIT 48300 BUKIT BERUNTUNG Selangor, MY |
| Product Code | LYY |
| 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 |