Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Riverstone Resources Sdn Bhd · Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

111 daysmedian FDA review time
249 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220672Blue Powder Free Nitrile Examination Glove with Grape ScenteRiverstone Resources Sdn Bhd2022-06-03880
K220401Pink Powder Free Nitrile Examination Glove With Bubblegum ScRiverstone Resources Sdn Bhd2022-04-09570
K200326Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd2020-04-09590
K190725Nitrile Examination Glove Sterile Tested for use with ChemotRiverstone Resources Sdn Bhd2019-12-172720
K180452White Nitrile Examination Glove, Sterile with Chemotherapy DRiverstone Resources Sdn Bhd2018-06-121120
K152542Powder Free Nitrile Examination Glove (Blue) With Low DermatRiverstone Resources Sdn Bhd2015-12-241110
K133193RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)Riverstone Resources Sdn Bhd2014-06-232490
K112924RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR ORiverstone Resources Sdn Bhd2012-05-022120
K112928RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREERiverstone Resources Sdn Bhd2012-04-171970
K100611RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)Riverstone Resources Sdn Bhd2010-07-161350
K100603RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREERiverstone Resources Sdn Bhd2010-07-1613524
K003233RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERRiverstone Resources Sdn Bhd2000-11-03170
K003232RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-SRiverstone Resources Sdn Bhd2000-10-2690
K992558NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILERiverstone Resources Sdn Bhd1999-09-27590
K990963RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-SRiverstone Resources Sdn Bhd1999-05-26640

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda