Data / Medical devices / Thailand / Ansell (thailand) Ltd.
Ansell (thailand) Ltd.: FDA-registered device maker in THAILAND Krung Thep Maha Nakhon, Thailand, 2 510(k) clearances
Ansell (thailand) Ltd. is registered with the FDA (registration 9610406) in THAILAND Krung Thep Maha Nakhon, Thailand. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610406
- FEI number
- 3002806370
- Address
- 74 Soi Chalongkrung 31 Khwang Lamplatiew, Khet Lat Krabang, THAILAND Krung Thep Maha Nakhon, Thailand, 10520
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Manufacturer
- First device listed
- June 14, 2021
- Registered through
- 2026
- Brand names listed
- PI Hybrid Micro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | 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 | 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 |
|---|---|---|---|---|---|---|
| October 20, 2023 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | KGO | Substantially Equivalent | Ansell Healthcare | accessdata.fda.gov |
| June 13, 2021 | K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Surgeon'S Gloves
Updated October 20, 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.