The following data is part of a premarket notification filed by Riverstone Resources Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove (blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs.
| Device ID | K152542 |
| 510k Number | K152542 |
| Device Name: | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim And With Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | RIVERSTONE RESOURCES SDN BHD LOT 55 & 56, NO13, JALAN JASMIN 2, KAWASAN PERINDUSTRIAN BUKIT BERUNTUNG Bukit Beruntung, MY 48300 |
| Contact | Suresh Kumar |
| Correspondent | Suresh Kumar RIVERSTONE RESOURCES SDN BHD LOT 55 & 56, NO13, JALAN JASMIN 2, KAWASAN PERINDUSTRIAN BUKIT BERUNTUNG 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 | 2015-09-04 |
| Decision Date | 2015-12-24 |
| Summary: | summary |