Data / Medical devices / Thailand / Top Glove Medical (thailand) Co., Ltd.
Top Glove Medical (thailand) Co., Ltd.: FDA-registered device maker in Sadao District Songkhla, Thailand, 4 510(k) clearances
Top Glove Medical (thailand) Co., Ltd. is registered with the FDA (registration 3003851058) in Sadao District Songkhla, Thailand. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003851058
- Address
- 188, 189, Mu 5 Kanchanawit Road. Samnak Kham Sub-District, Sadao District Songkhla, Thailand, 90320
- Owner or operator
- TOP GLOVE MEDICAL (THAILAND) CO., LTD. (9051679)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 31, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, 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 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| June 3, 1999 | K990668 | POWDER FREE BLUE NITRILE GLOVE | LZA | 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 Latex Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
Updated February 10, 2023. 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.