Data / Medical devices / Malaysia / Kossan International Sdn Bhd
Kossan International Sdn Bhd: FDA-registered device maker in Shah Alam Selangor, Malaysia, 41 510(k) clearances
Kossan International Sdn Bhd is registered with the FDA (registration 3009538921) in Shah Alam Selangor, Malaysia. It lists 6 device types. The FDA files 41 510(k) clearances under its listings, the newest dated January 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009538921
- Address
- KOSSAN Tower, No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13, Shah Alam Selangor, Malaysia, 40170
- Owner or operator
- Kossan International Sdn Bhd (10039751)
- Roles
- Exporter to the US, Specification developer
- First device listed
- February 7, 2012
- 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 |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| January 13, 2026 | K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 23, 2024 | K241780 | Cardinal Health Nitrile Exam Gloves | LZA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| November 14, 2023 | K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| June 13, 2023 | K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | LYY | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| March 15, 2023 | K223375 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. | LZA | Substantially Equivalent | Kossan International Sdn Bhd3 | accessdata.fda.gov |
| July 13, 2020 | K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Medline Industires, Inc. | accessdata.fda.gov |
| May 28, 2019 | K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| April 5, 2019 | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| September 29, 2017 | K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | KGO | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| July 10, 2017 | K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 3, 2016 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 2, 2016 | K160467 | Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 2, 2016 | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| February 12, 2015 | K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| April 8, 2014 | K133949 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| March 5, 2013 | K123819 | MULTIPLE NAME | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| February 19, 2013 | K123469 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE | LZA | Substantially Equivalent | Wear Safe (Malaysia) Sdn Bhd - Facility II | accessdata.fda.gov |
| November 16, 2012 | K123026 | TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO | LYY | Substantially Equivalent | Northstar Healthcare Holdings | accessdata.fda.gov |
| July 5, 2012 | K121464 | BLUE POWER FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Northstar Healthcare Holdings | accessdata.fda.gov |
| May 14, 2012 | K120692 | LATEX EXAMINATION GLOVES (POWDER FREE) | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| January 18, 2012 | K112612 | POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM | LYY | Substantially Equivalent | Top Calibre Sdn Bhd | accessdata.fda.gov |
| November 9, 2011 | K112988 | POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE | LYY | Substantially Equivalent | Northstar Healthcare Holdings Limited | 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 |
| November 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| January 19, 2010 | K093500 | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE | LZC | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| September 21, 2009 | K092327 | MICRO-TOUCH NITRA FREE | LZA | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| May 15, 2009 | K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | KGO | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| April 3, 2009 | K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | 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 |
| February 27, 2007 | K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED | LZC | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| December 22, 2006 | K062965 | CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| October 27, 2006 | K062778 | STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | LZA | Substantially Equivalent | Wear Safe Malaysia Sdn. Bhd. | accessdata.fda.gov |
| May 1, 2006 | K060771 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED | LZA | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| August 3, 2005 | K051378 | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Medline | accessdata.fda.gov |
| October 22, 2003 | K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED | LZC | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| June 26, 2003 | K031591 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED | LZA | Substantially Equivalent | Perusahaan Getah Asas Sdn. Bhd. | accessdata.fda.gov |
| February 15, 2001 | K010211 | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES | LZC | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| May 23, 2000 | K001190 | POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE | LYY | Substantially Equivalent | Kossan Latex Industries(M)Sdn Bhd | accessdata.fda.gov |
| May 4, 1989 | K892086 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | Cypress Medical Products, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Surgeon'S Gloves
Updated January 13, 2026. 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.