Data / Medical devices / Thailand / Dipped Products (thailand) Ltd
Dipped Products (thailand) Ltd: FDA-registered device maker in AMPHUR KHUN NIENG Songkhla, Thailand, 4 510(k) clearances
Dipped Products (thailand) Ltd is registered with the FDA (registration 3005024094) in AMPHUR KHUN NIENG Songkhla, Thailand. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 29, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005024094
- Address
- 82/2 Moo 9, Tumbon Rattapum, AMPHUR KHUN NIENG Songkhla, Thailand, 90220
- Owner or operator
- DIPPED PRODUCTS (THAILAND) LTD (9069755)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- PALM PRO, PALM PRO NITRILE POWDER FREE EXAMINATION GLOVES, PALM PRO PREMIUM, PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES, PALMPRO X-POWDER FREE LATEX EXAMINATION GLOVES (6PF2G30), SW N20036 Exam GLOVES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 29, 2017 | K161929 | Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove | LZA | Substantially Equivalent | Dipped Products (Thailand) Limited | accessdata.fda.gov |
| April 19, 2012 | K111464 | PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Dipped Products (Thailand), Ltd. | accessdata.fda.gov |
| May 27, 2011 | K100895 | PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) | LYY | Substantially Equivalent | Dipped Products Limited | accessdata.fda.gov |
| February 7, 2005 | K050152 | PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE | LYY | Substantially Equivalent | Dipped Products (Thailand), Ltd. | 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
Updated March 29, 2017. 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.