Atlas FDA

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

Pamitex Industries Sdn Bhd · Predicate Candidate Screening

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

69 daysmedian FDA review time
175 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER Pamitex Industries Sdn Bhd2001-04-051610
K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATIOPamitex Industries Sdn Bhd2000-06-30980
K001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLORPamitex Industries Sdn Bhd2000-06-30290
K001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVESPamitex Industries Sdn Bhd2000-06-23220
K993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SPamitex Industries Sdn Bhd2000-04-281750
K000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATIPamitex Industries Sdn Bhd2000-04-07240
K993201HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SUPamitex Industries Sdn Bhd2000-03-291870
K993918HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX Pamitex Industries Sdn Bhd2000-02-10840
K993621HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMPamitex Industries Sdn Bhd1999-12-29640
K993093HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)Pamitex Industries Sdn Bhd1999-10-29430
K993097HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINPamitex Industries Sdn Bhd1999-10-27410
K992523HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXPamitex Industries Sdn Bhd1999-10-18820
K991474HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMIPamitex Industries Sdn Bhd1999-10-061620
K992117PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDERPamitex Industries Sdn Bhd1999-09-27960
K992364HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION Pamitex Industries Sdn Bhd1999-09-22690
K991969HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATIPamitex Industries Sdn Bhd1999-09-09900
K992223HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATIPamitex Industries Sdn Bhd1999-08-30600
K992165HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATIONPamitex Industries Sdn Bhd1999-08-25580
K992299HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATPamitex Industries Sdn Bhd1999-08-23460

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