Atlas FDA

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

Supermax Glove Manufacturing Sdn Bhd · Predicate Candidate Screening

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

70 daysmedian FDA review time
88 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K024083GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PESupermax Glove Manufacturing Sdn Bhd2003-01-10300
K014230STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELISupermax Glove Manufacturing Sdn Bhd2002-03-13770
K013953AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLSupermax Glove Manufacturing Sdn Bhd2002-02-26880
K013589CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITSupermax Glove Manufacturing Sdn Bhd2002-01-08700
K010198STERILE POWDERED LATEX SURGEON GLOVESSupermax Glove Manufacturing Sdn Bhd2001-02-23320
K000644SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVESSupermax Glove Manufacturing Sdn Bhd2000-03-17210

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