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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003922 | NITRILE EXAMINATION GLOVES (POWERED) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-15 | 57 | 0 |
| K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-02-09 | 45 | 0 |
| K010078 | GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FR | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-29 | 19 | 0 |
| K010054 | GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-26 | 18 | 0 |
| K003872 | GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN | Guthrie Medicare Products (Melaka) Sdn Bhd | 2001-01-23 | 39 | 0 |
| K001049 | GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-05-23 | 53 | 0 |
| K001047 | GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-04-28 | 28 | 0 |
| K000090 | GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GL | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-02-10 | 28 | 0 |
| K993793 | GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE | Guthrie Medicare Products (Melaka) Sdn Bhd | 2000-01-12 | 64 | 0 |
| K990228 | GUTHRIE PRIME POWDER-FREE | Guthrie Medicare Products (Melaka) Sdn Bhd | 1999-02-19 | 25 | 0 |
| K954967 | GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES | Guthrie Medicare Products (Melaka) Sdn Bhd | 1996-04-15 | 168 | 0 |
| K911694 | PATIENT EXAMINATION LATEX GLOVES (NON-STERILE) | Guthrie Medicare Products (Melaka) Sdn Bhd | 1991-04-25 | 9 | 0 |
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