Data / Medical devices / Thailand / Cardinal Health 222 (thailand) Limited
Cardinal Health 222 (thailand) Limited: FDA-registered device maker in PLUAKDAENG Rayong, Thailand, 17 510(k) clearances
Cardinal Health 222 (thailand) Limited is registered with the FDA (registration 3013516822) in PLUAKDAENG Rayong, Thailand. It lists 2 device types. The FDA files 17 510(k) clearances under its listings, the newest dated September 26, 2021. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013516822
- Address
- 7/159 Moo 4 Highway, #331 Mabyangporn, PLUAKDAENG Rayong, Thailand, 21140
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Manufacturer
- First device listed
- December 31, 1977
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 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 |
|---|---|---|---|---|---|---|
| September 26, 2021 | K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | KGO | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| July 11, 2016 | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 12, 2016 | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| September 29, 2011 | K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 21, 2011 | K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| June 8, 2011 | K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 6, 2011 | K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| October 15, 2010 | K101811 | PROTEGRITY SMT LATEX SURGICALGLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| October 30, 2009 | K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 15, 2009 | K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| April 27, 2004 | K033905 | PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| October 15, 2003 | K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| August 14, 2001 | K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| July 14, 2000 | K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| September 14, 1999 | K992171 | COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
Compare with other makers
Updated September 26, 2021. 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.