Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Best Manufacturing Company · Predicate Candidate Screening

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

71 daysmedian FDA review time
122 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022024NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)Best Manufacturing Company2002-08-01420
K012899GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVEBest Manufacturing Company2001-09-18200
K012166NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)Best Manufacturing Company2001-08-01210
K001375ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FBest Manufacturing Company2000-07-25850
K993805NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GBest Manufacturing Company2000-03-101220
K992170N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVEBest Manufacturing Company1999-09-07710

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