The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for Blue Powder Free Nitrile Examination Glove With Grape Scented, Chemotherapy Drugs And Fentanyl Test Claim.
| Device ID | K220672 |
| 510k Number | K220672 |
| Device Name: | Blue Powder Free Nitrile Examination Glove With Grape Scented, Chemotherapy Drugs And Fentanyl Test Claim |
| Classification | Polymer Patient Examination Glove |
| Applicant | Riverstone Resources Sdn Bhd Lot 20852, No.119, Jalan Logam 7 Kamunting Raya Industrial Estate Taiping, MY 34600 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar Riverstone Resources Sdn Bhd Lot 20852, No.119, Jalan Logam 7 Kamunting Raya Industrial Estate Taiping, MY 34600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-06-03 |