Data / Medical devices / Malaysia / Riverstone Resources Sdn. Bhd.
Riverstone Resources Sdn. Bhd.: FDA-registered device maker in BUKIT BERUNTUNG, Selangor, Malaysia, 8 510(k) clearances
Riverstone Resources Sdn. Bhd. is registered with the FDA (registration 9617453) in BUKIT BERUNTUNG, Selangor, Malaysia. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9617453
- FEI number
- 3003158169
- Address
- LOT 55, NO. 13, JALAN JASMIN 2 Kawasan Perindustrian, Bukit Beruntung, BUKIT BERUNTUNG, Selangor, Malaysia, 48300
- Owner or operator
- RIVERSTONE RESOURCES SDN. BHD. (8040854)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 1, 2007
- Registered through
- 2026
- Brand names listed
- Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim, Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim, Get-A-Grip, Halyard Purple Nitrile Max Powder -Free Exam Glove for use with Chemotherapy Drugs, Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim, White Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2020 | K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| December 17, 2019 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| June 12, 2018 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| June 23, 2014 | K133193 | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| May 2, 2012 | K112924 | RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| April 17, 2012 | K112928 | RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| July 16, 2010 | K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| October 26, 2000 | K003232 | RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Finger Cot
Updated April 9, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.