Atlas FDA

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

Pt. Wrp Buana Multicorpora · Predicate Candidate Screening

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

58 daysmedian FDA review time
145 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032010GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-SPt. Wrp Buana Multicorpora2003-08-19500
K032011GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-SPt. Wrp Buana Multicorpora2003-08-19500
K032007GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STEPt. Wrp Buana Multicorpora2003-07-28280
K030273GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERIPt. Wrp Buana Multicorpora2003-03-26580
K022343GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (Pt. Wrp Buana Multicorpora2002-09-16590
K994426GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PRPt. Wrp Buana Multicorpora2000-05-231450

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