Data / Medical devices / Thailand / Hi-Care Thai Gloves Co Ltd
Hi-Care Thai Gloves Co Ltd: FDA-registered device maker in HATYAI Songkhla, Thailand, 2 510(k) clearances
Hi-Care Thai Gloves Co Ltd is registered with the FDA (registration 3020764656) in HATYAI Songkhla, Thailand. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020764656
- Address
- 89/1, Moo 4, Tambon Chalung, HATYAI Songkhla, Thailand, 90110
- Owner or operator
- HI-CARE THAI GLOVES CO LTD (10082780)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 5, 2021
- Registered through
- 2026
- Brand names listed
- Blue Nitrile Examination Gloves Powder Free, House Brand Dentistry, Latex Examination Powder Free Gloves, Palm Care Blue Nitrile Examination Gloves Powder Free, Palm Care Latex Examination Powder Free Gloves, Palmshield Nitrile Powder Free Examination Gloves, SAFETYMAX, STRONGHOLD GROUP NITRILE EXAMINATION GLOVE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 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 |
|---|---|---|---|---|---|---|
| December 2, 2020 | K202384 | Palm Care Blue Nitrile Examination Gloves Powder Free | LZA | Substantially Equivalent | Hi-Care Thai Gloves Co. , Ltd. | accessdata.fda.gov |
| December 1, 2020 | K202377 | Palm Care Latex Examination Powder Free Gloves | LYY | Substantially Equivalent | Hi-Care Thai Gloves Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 2, 2020. 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.