Data / Medical devices / Malaysia / Riverstone Resources Sdn Bhd
Riverstone Resources Sdn Bhd: FDA-registered device maker in TAIPING Perak, Malaysia, 10 510(k) clearances
Riverstone Resources Sdn Bhd is registered with the FDA (registration 3011211126) in TAIPING Perak, Malaysia. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011211126
- Address
- Lot 20852,No 119,Jalan Logam 7, Kamunting Raya, Industrial Estate, TAIPING Perak, Malaysia, 34600
- Owner or operator
- Riverstone Resources (10047574)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 7, 2014
- 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, EMG Pink Nitrile Examination Glove Powder Free, Get-A-Grip, Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim, White Nitrile Medical Examination Glove Powder Free
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 3, 2022 | K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| April 9, 2022 | K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| December 24, 2015 | K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| October 7, 2014 | K141623 | EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| October 7, 2014 | K141510 | EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Eco Medi Glove 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 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | 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
Updated June 3, 2022. 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.