The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (aqua Green).
| Device ID | K200326 |
| 510k Number | K200326 |
| Device Name: | Powder Free Nitrile Examination Glove (Aqua Green) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Riverstone Resources SDN BHD Lot 55, No 13 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, MY 48300 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar Riverstone Resources SDN BHD Lot 55, No 13 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 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 | 2020-02-10 |
| Decision Date | 2020-04-09 |