Riverstone Resources Sdn Bhd: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Riverstone Resources Sdn Bhd” (first 1999, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 88 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 204 |
| 2013 | 0 | — |
| 2014 | 1 | 249 |
| 2015 | 1 | 111 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 112 |
| 2019 | 1 | 272 |
| 2020 | 1 | 59 |
| 2021 | 0 | — |
| 2022 | 2 | 72 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Riverstone Resources Sdn Bhd took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 14 | 14 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (15)
Most recent Riverstone Resources Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | LZA | 2022-06-03 | 88 |
| K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim | LZA | 2022-04-09 | 57 |
| K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | LZA | 2020-04-09 | 59 |
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | LZA | 2019-12-17 | 272 |
| K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | LZA | 2018-06-12 | 112 |
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs | LZA | 2015-12-24 | 111 |
| K133193 | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | 2014-06-23 | 249 |
| K112924 | RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME | LZA | 2012-05-02 | 212 |
| K112928 | RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME | LZA | 2012-04-17 | 197 |
| K100611 | RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) | LYY | 2010-07-16 | 135 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Riverstone Resources Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Riverstone Resources Sdn Bhd?
FDA lists 15 510(k) clearances under the applicant name “Riverstone Resources Sdn Bhd” (first 1999, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Riverstone Resources Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Riverstone Resources Sdn Bhd is 111 days. Since 2017: 88 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Riverstone Resources Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 14); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 15 Riverstone Resources Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Riverstone Resources Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.