Atlas FDA

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

Purna Bina Sdn Bhd · Predicate Candidate Screening

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

74 daysmedian FDA review time
585 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130450SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER Purna Bina Sdn Bhd2014-09-305850
K083571ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLAPurna Bina Sdn Bhd2009-08-132530
K041004ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EPurna Bina Sdn Bhd2004-07-02740
K022659ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EPurna Bina Sdn Bhd2002-09-25470
K003904POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVESPurna Bina Sdn Bhd2001-01-24360
K994420POWDER FREE LATEX EXAMINATION PATIENT GLOVESPurna Bina Sdn Bhd2000-09-182640
K891507PATIENT EXAMINATION GLOVES (LATEX)Purna Bina Sdn Bhd1989-04-06210

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