Atlas FDA

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

Best Putra Gloves Sdn Bhd · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K101105POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MBest Putra Gloves Sdn Bhd2010-11-102040
K101106POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1Best Putra Gloves Sdn Bhd2010-11-102040
K101102POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILEBest Putra Gloves Sdn Bhd2010-07-16870
K101103POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODELBest Putra Gloves Sdn Bhd2010-07-16870

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