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

Pt Mahakarya Inti Buana · Predicate Candidate Screening

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

105 daysmedian FDA review time
186 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K111300SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERIPt Mahakarya Inti Buana2011-08-12950
K090464BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILEPt Mahakarya Inti Buana2009-04-23590
K063581SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED,Pt Mahakarya Inti Buana2007-03-151050
K062313SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NPt Mahakarya Inti Buana2006-11-301140
K061233SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILEPt Mahakarya Inti Buana2006-11-031850
K053305SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILEPt Mahakarya Inti Buana2006-06-021860
K053366NITRILE EXAMINATION GLOVES, POWDERED, NON STERILEPt Mahakarya Inti Buana2006-03-301150
K053657POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILEPt Mahakarya Inti Buana2006-02-13700
K052273POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STPt Mahakarya Inti Buana2005-09-30390

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