Data / Medical devices / Thailand / Sri Trang Gloves (thailand) Public Company Limited.
Sri Trang Gloves (thailand) Public Company Limited.: FDA-registered device maker in Hat Yai Songkhla, Thailand, 24 510(k) clearances
Sri Trang Gloves (thailand) Public Company Limited. is registered with the FDA (registration 1000266564) in Hat Yai Songkhla, Thailand. It lists 5 device types. The FDA files 24 510(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
- 1000266564
- Address
- 10 Soi 10 Phetkasem Road Hat Yai, Hat Yai Songkhla, Thailand, 90110
- Owner or operator
- SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. (8041108)
- Roles
- Exporter to the US, Specification developer
- First device listed
- August 17, 1989
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Specification developer | 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 |
| August 9, 2022 | K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | LYY | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| April 8, 2022 | K212309 | Non-sterile, Powder-Free Latex Examination Glove | LYY | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| February 12, 2021 | K203191 | LYDUS Nitrile Examination Gloves, Powder Free | LZA | Substantially Equivalent | Nathan Trading Co., Ltd. | 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 |
| May 30, 2019 | K182308 | Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Co., Ltd. | accessdata.fda.gov |
| March 11, 2019 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Co., Ltd. | accessdata.fda.gov |
| February 11, 2015 | K142685 | NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| December 27, 2012 | K121549 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | 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 |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | 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 |
| September 3, 2008 | K081907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| December 20, 2002 | K024121 | NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| December 20, 2002 | K024106 | NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM | LYY | 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 |
| April 5, 2000 | K000329 | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE | LZA | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| November 15, 1995 | K954880 | LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- 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.