Data / Medical devices / Thailand / Safeskin Medical & Scientific (thailand), Ltd.
Safeskin Medical & Scientific (thailand), Ltd.: FDA-registered device maker in SADAO Songkhla, Thailand, 29 510(k) clearances
Safeskin Medical & Scientific (thailand), Ltd. is registered with the FDA (registration 9614175) in SADAO Songkhla, Thailand. It lists 4 device types. The FDA files 29 510(k) clearances under its listings, the newest dated August 18, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9614175
- FEI number
- 1000297006
- Address
- 200 Moo 8 Kanchanavanich Road Tambol Prik, SADAO Songkhla, Thailand, 90120
- Owner or operator
- O&M Halyard, Inc. (10057479)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 2, 2018
- Registered through
- 2026
- Brand names listed
- EXAMINATION GLOVE, SPECIALTY, FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES, Fusion Black Powder-Free Nitrile Exam Glove, Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove, Halyard Lavender Nitrile Powder-Free Exam Gloves, Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta, Halyard Pink Underguard Nitrile Powder-Free Exam Glove, Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs and more
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, Specification developer | 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 |
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 |
|---|---|---|---|---|---|---|
| August 18, 2025 | K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 18, 2025 | K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| September 27, 2024 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 22, 2024 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 16, 2022 | K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| August 1, 2022 | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 2, 2022 | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 2, 2022 | K220541 | PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| November 19, 2021 | K211063 | HALYARD Flexaprene Green Powder-Free Exam Glove | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| January 7, 2021 | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| October 11, 2020 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | LZC | Substantially Equivalent | 0 & M Halyard, Inc. | accessdata.fda.gov |
| September 22, 2020 | K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 13, 2020 | K192241 | Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | O&M Haylard, Inc. | accessdata.fda.gov |
| November 8, 2019 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 26, 2019 | K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| February 5, 2019 | K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| November 2, 2018 | K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Owens & Minor Halyard, Inc. | accessdata.fda.gov |
| June 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| September 6, 2016 | K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| March 31, 2016 | K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| June 18, 2015 | K150113 | Fusion Black Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| March 9, 2012 | K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| September 8, 2010 | K102032 | KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | LZC | Substantially Equivalent | Kimberly-Clark | accessdata.fda.gov |
| July 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| June 30, 2008 | K081027 | KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE) | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| August 30, 1999 | K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | LZC | Substantially Equivalent | Safeskin Corp. | accessdata.fda.gov |
| December 19, 1996 | K962139 | SAFESKIN | LZA | Substantially Equivalent | Safeskin Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated August 18, 2025. 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.