The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for Nitrile Examination Glove Sterile Tested For Use With Chemotherapy Drugs Claim, White.
| Device ID | K190725 |
| 510k Number | K190725 |
| Device Name: | Nitrile Examination Glove Sterile Tested For Use With Chemotherapy Drugs Claim, White |
| Classification | Polymer Patient Examination Glove |
| Applicant | Riverstone Resources SDN BHD Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, MY 48300 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar Riverstone Resources SDN BHD Lot 56, No 15, Jalan Jasmin 2 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 | 2019-03-20 |
| Decision Date | 2019-12-17 |