Atlas FDA

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

Biopro (M) Sdn Bhd — Predicate Candidate Screening

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

70 daysmedian FDA review time
305 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994276BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATIOBiopro (M) Sdn Bhd2000-10-203050
K994281BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATIBiopro (M) Sdn Bhd2000-10-203050
K994043CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVESBiopro (M) Sdn Bhd2000-01-11430
K992358CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUBiopro (M) Sdn Bhd1999-09-10580
K981333NITRILON CORRECT-TOUCHBiopro (M) Sdn Bhd1998-06-22700

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