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

Perusahaan Pelindung Getah (M) Sdn Bhd · Predicate Candidate Screening

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

84 daysmedian FDA review time
273 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K072300POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINAPerusahaan Pelindung Getah (M) Sdn Bhd2008-05-162730
K032201RUBBERCARE POWDERED LATEX EXAMINATION GLOVESPerusahaan Pelindung Getah (M) Sdn Bhd2003-10-10840
K002111RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/Perusahaan Pelindung Getah (M) Sdn Bhd2000-09-08580
K002112RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-Perusahaan Pelindung Getah (M) Sdn Bhd2000-08-14330
K002114RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINAPerusahaan Pelindung Getah (M) Sdn Bhd2000-08-11300
K994201RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVPerusahaan Pelindung Getah (M) Sdn Bhd2000-02-07560
K933759RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDEREDPerusahaan Pelindung Getah (M) Sdn Bhd1994-03-212430
K891123RUBBERCARE PATIENT EXAMINATION GLOVEPerusahaan Pelindung Getah (M) Sdn Bhd1989-07-141340

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