# Riverstone Resources Sdn Bhd

- Location (FDA's records): Bukit Beruntung, MY
- FDA decisions: 15 (1999–2022): 15 510(k) clearances
- Product codes: LZA (14), LYY (1)
- 510(k) review time since 2016: median 88 days, against 111 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 19 (5 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eco Medi Glove Sdn. Bhd.: 3 (https://510kreport.com/company/eco-medi-glove-sdn-bhd)
- Smart Glove Corp. Sdn Bhd: 1 (https://510kreport.com/company/smart-glove-sdn-bhd)
- Sanrea Healthcare Products Pvt, Ltd.: 1 (https://510kreport.com/company/sanrea-healthcare-products-pvt)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)

## Firms that cite its devices most
- Eco Medi Glove Sdn. Bhd.: 6 (https://510kreport.com/company/eco-medi-glove-sdn-bhd)
- Professional Latex Sdn Bhd: 1 (https://510kreport.com/company/professional-latex-sdn-bhd)
- Nam Viet Glove Joint Stock Company: 1 (https://510kreport.com/company/nam-viet-glove-joint-stock)
- Grand Work Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/grand-work-plastic-products)
- Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.: 1 (https://510kreport.com/company/jiangxi-kemei-medical-apparatus-instruments-group)
- Dongguan Grinvald Technology Co., Ltd.: 1 (https://510kreport.com/company/dongguan-grinvald-technology)
- Worldmed Manufacturing Sdn. Bhd.: 1 (https://510kreport.com/company/worldmed-manufacturing-sdn-bhd)
- Avecena Gloves Sdn Bhd: 1 (https://510kreport.com/company/avecena-gloves-sdn-bhd)

## Its most-cited devices
- K100603: RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) (2010), cited by 6
- K200326: Powder Free Nitrile Examination Glove (Aqua Green) (2020), cited by 4
- K112928: RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name (2012), cited by 3
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (2015), cited by 2
- K112924: RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name (2012), cited by 2
- K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (2018), cited by 1

## Recent decisions
- K220672: Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim (Jun 3, 2022)
- K220401: Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim (Apr 9, 2022)
- K200326: Powder Free Nitrile Examination Glove (Aqua Green) (Apr 9, 2020)
- K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (Dec 17, 2019)
- K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (Jun 12, 2018)
- K152542: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs (Dec 24, 2015)
- K133193: RS Orange Nitrile Medical Examination Gloves (Powder Free) (Jun 23, 2014)
- K112924: RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name (May 2, 2012)

Source page: https://510kreport.com/company/riverstone-resources-sdn-bhd