Guthrie Medicare Products (Melaka) Sdn Bhd: FDA clearances and approvals
Guthrie Medicare Products (Melaka) Sdn Bhd has 12 FDA 510(k) clearances (first 1991, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time: 34 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 8 | 8 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (12)
Most recent Guthrie Medicare Products (Melaka) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003922 | NITRILE EXAMINATION GLOVES (POWERED) | LZA | 2001-02-15 | 57 |
| K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | 2001-02-09 | 45 |
| K010078 | GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) | LYY | 2001-01-29 | 19 |
| K010054 | GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | 2001-01-26 | 18 |
| K003872 | GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | 2001-01-23 | 39 |
| K001049 | GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) | KGO | 2000-05-23 | 53 |
| K001047 | GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) | KGO | 2000-04-28 | 28 |
| K000090 | GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES | LYY | 2000-02-10 | 28 |
| K993793 | GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE | LYY | 2000-01-12 | 64 |
| K990228 | GUTHRIE PRIME POWDER-FREE | LYY | 1999-02-19 | 25 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guthrie Medicare Products (Melaka) Sdn Bhd.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Guthrie Medicare Products (Melaka) Sdn Bhd have?
Guthrie Medicare Products (Melaka) Sdn Bhd has 12 FDA 510(k) clearances (first 1991, latest 2001), across 3 product codes in 1 review panel.
How long does FDA take to clear Guthrie Medicare Products (Melaka) Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Guthrie Medicare Products (Melaka) Sdn Bhd's cleared 510(k)s is 34 days.
What devices does Guthrie Medicare Products (Melaka) Sdn Bhd make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 8); KGO (Surgeon'S Gloves, 2); LZA (Polymer Patient Examination Glove, 2).
Has Guthrie Medicare Products (Melaka) Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Guthrie Medicare Products (Melaka) Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 12 Guthrie Medicare Products (Melaka) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Guthrie Medicare Products (Melaka) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.