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

Guthrie Medicare Products (Melaka) Sdn Bhd · Predicate Candidate Screening

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

39 daysmedian FDA review time
64 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003922NITRILE EXAMINATION GLOVES (POWERED)Guthrie Medicare Products (Melaka) Sdn Bhd2001-02-15570
K003985POWDERFREE NITRILE PATIENT EXMINATION GLOVEGuthrie Medicare Products (Melaka) Sdn Bhd2001-02-09450
K010078GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FRGuthrie Medicare Products (Melaka) Sdn Bhd2001-01-29190
K010054GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH Guthrie Medicare Products (Melaka) Sdn Bhd2001-01-26180
K003872GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEINGuthrie Medicare Products (Melaka) Sdn Bhd2001-01-23390
K001049GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMSGuthrie Medicare Products (Melaka) Sdn Bhd2000-05-23530
K001047GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)Guthrie Medicare Products (Melaka) Sdn Bhd2000-04-28280
K000090GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLGuthrie Medicare Products (Melaka) Sdn Bhd2000-02-10280
K993793GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVEGuthrie Medicare Products (Melaka) Sdn Bhd2000-01-12640
K990228GUTHRIE PRIME POWDER-FREEGuthrie Medicare Products (Melaka) Sdn Bhd1999-02-19250
K954967GUTHRIE POWDERFREE LATEX EXAMINATION GLOVESGuthrie Medicare Products (Melaka) Sdn Bhd1996-04-151680
K911694PATIENT EXAMINATION LATEX GLOVES (NON-STERILE)Guthrie Medicare Products (Melaka) Sdn Bhd1991-04-2590

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