Data / Medical devices / Thailand / STGT PS1
STGT PS1: FDA-registered device maker in Sadao Songkhla, Thailand, 10 510(k) clearances
STGT PS1 is registered with the FDA (registration 3019849096) in Sadao Songkhla, Thailand. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 2, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3019849096
- Address
- 207/1 Padang Besa Road Sadao, Sadao Songkhla, Thailand, 90120
- Owner or operator
- SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. (8041108)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 27, 2007
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 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 | 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 |
|---|---|---|---|---|---|---|
| July 2, 2024 | K240930 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue | LZA | Substantially Equivalent | Sri Trang Gloves Thailand (Public Company Limited) | accessdata.fda.gov |
| May 13, 2024 | K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| November 20, 2022 | K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| April 9, 2020 | K200539 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| March 20, 2020 | K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| September 10, 2012 | K122363 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| June 24, 2011 | K111133 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) | LYY | Substantially Equivalent | Ssc Surat Thani | accessdata.fda.gov |
| July 9, 2010 | K100907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| March 5, 2009 | K083755 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| June 6, 2002 | K021220 | NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | 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 Latex Patient Examination Glove
Updated July 2, 2024. 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.