Data / Medical devices / Malaysia / TG Medical Sdn Bhd
TG Medical Sdn Bhd: FDA-registered device maker in KLANG Selangor, Malaysia, 16 510(k) clearances
TG Medical Sdn Bhd is registered with the FDA (registration 9680622) in KLANG Selangor, Malaysia. It lists 7 device types. The FDA files 16 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680622
- FEI number
- 3002808366
- Address
- Lot 5091, Jalan Teratai, BT 5 Off Jalan Meru, KLANG Selangor, Malaysia, 41050
- Owner or operator
- TG MEDICAL SDN BHD (9010202)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 20, 2008
- Registered through
- 2026
- Brand names listed
- Polymer Patient Examination Glove, TG MEDICAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Contract manufacturer | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 9, 2026 | K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| 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 |
| September 3, 2020 | K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| June 5, 2020 | K193150 | Latex Examination Powder Free Glove, Aloe Vera | LZA | Substantially Equivalent | Top Glove 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 |
| August 21, 2017 | K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Tg Medical 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 |
| September 11, 2012 | K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| December 29, 1999 | K993562 | POWDER FREE LATEX STERILE SURGICAL GLOVES | KGO | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| June 3, 1999 | K990668 | POWDER FREE BLUE NITRILE GLOVE | LZA | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| April 2, 1999 | K990495 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Flexitech Sdn. Bhd. | accessdata.fda.gov |
| October 15, 1998 | K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Dam, Rubber
- All makers of Surgeon'S Gloves
- All makers of Latex Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
Updated September 9, 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.