Atlas FDA

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

Supermax Sdn Bhd · Predicate Candidate Screening

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

112 daysmedian FDA review time
436 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013774CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WSupermax Sdn Bhd2002-03-051120
K993864COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVESSupermax Sdn Bhd2000-01-20660
K993865GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVESSupermax Sdn Bhd2000-01-20660
K993258SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVESSupermax Sdn Bhd1999-10-27280
K991415SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLSupermax Sdn Bhd1999-05-26330
K980966SUPERGLOVES POWDERED NITRILESupermax Sdn Bhd1998-07-221280
K980494SUPERGLOVESSupermax Sdn Bhd1998-06-091200
K915251PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENICSupermax Sdn Bhd1993-01-224360
K892287PATIENT EXAMINATION GLOVES (LATEX)Supermax Sdn Bhd1990-01-102790

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