Data / Medical devices / Malaysia / TG Worldwide Sdn. Bhd.
TG Worldwide Sdn. Bhd.: FDA-registered device maker in Shah Alam Selangor, Malaysia, 26 510(k) clearances
TG Worldwide Sdn. Bhd. is registered with the FDA (registration 3020521811) in Shah Alam Selangor, Malaysia. It lists 7 device types. The FDA files 26 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3020521811
- Address
- 16 Persiaran Setia Dagang, Shah Alam Selangor, Malaysia, 40170
- Owner or operator
- TG WORLDWIDE SDN. BHD. (10082693)
- Roles
- Exporter to the US
- First device listed
- September 9, 2021
- Registered through
- 2026
- Brand names listed
- Finessis Corium, Finessis Zero, PATIENT EXAMINATION GLOVE, POLYMER PATIENT EXAMINATION GLOVE, SURGEON GLOVE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Exporter to the US | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | 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 |
| August 18, 2023 | K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | KGO | Substantially Equivalent | Sentienx 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 |
| April 26, 2018 | K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | 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 |
| March 31, 2017 | K162626 | THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE | LZA | Substantially Equivalent | Top Quality Glove 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 |
| October 15, 2002 | K022016 | POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Top Glove Medical (Thailand) Co., Ltd. | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | 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 |
| January 31, 2000 | K994354 | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Flexitech 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 |
| February 19, 1999 | K990228 | GUTHRIE PRIME POWDER-FREE | LYY | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
| December 4, 1998 | K983825 | NITRILE LATEX POWDER FREE EXAMINATION GLOVE | LZA | Substantially Equivalent | Top Glove 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 Surgeon'S Gloves
- 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 Medical Glove, Specialty
- All makers of Latex Patient Examination 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.