Data / Medical devices / Malaysia / GMP Medicare Sdn Bhd(F25)
GMP Medicare Sdn Bhd(F25): FDA-registered device maker in Klang Selangor, Malaysia, 13 510(k) clearances
GMP Medicare Sdn Bhd(F25) is registered with the FDA (registration 3006796582) in Klang Selangor, Malaysia. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006796582
- Address
- Lot/PT 64593, Jalan Dahlia/KU8 Kawasan Perindustrian Meru Timur, Klang Selangor, Malaysia, 41050
- Owner or operator
- GMP MEDICARE SDN BHD (9076939)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 31, 2007
- Registered through
- 2026
- Brand names listed
- Polymer Patient Examination Glove
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| April 23, 2025 | K250944 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| February 10, 2023 | K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Top Glove Medical (Thailand) Co., Ltd. | accessdata.fda.gov |
| February 24, 2021 | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| August 29, 2019 | K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | LZC | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| May 10, 2018 | K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | LZA | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| March 22, 2017 | K163017 | Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
| April 21, 2016 | K152222 | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs | LZC | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| January 29, 2001 | K010078 | GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) | LYY | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| May 23, 2000 | K001049 | GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| February 10, 2000 | K000090 | GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| February 19, 1999 | K990228 | GUTHRIE PRIME POWDER-FREE | LYY | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Surgeon'S Gloves
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.