Atlas FDA

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

Pwa Industries Sdn. Bhd. · Predicate Candidate Screening

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

49 daysmedian FDA review time
116 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011895POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATPwa Industries Sdn. Bhd.2001-07-09210
K010077HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATIPwa Industries Sdn. Bhd.2001-02-28490
K001485HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATIOPwa Industries Sdn. Bhd.2000-06-13320
K001475HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CPwa Industries Sdn. Bhd.2000-06-13330
K981774MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1998-07-24650
K973913MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1997-12-18650
K973551MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1997-11-06480
K972169MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1997-10-031160
K964724POWDER-FREE LATEX EXAMINATION GLOVESPwa Industries Sdn. Bhd.1997-06-162130
K963560MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1996-10-24490
K953138MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.1995-09-22780

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