# Kossan International Sdn Bhd

- Location (FDA's records): Klang, MY
- FDA decisions: 13 (2015–2026): 13 510(k) clearances
- Product codes: LZA (12), LYY (1)
- 510(k) review time since 2016: median 151 days, against 171 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gx Corporation Sdn Bhd: 2 (https://510kreport.com/company/gx-sdn-bhd)
- Northstar Healthcare Holdings: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Perusahaan Getah Asas Sdn. Bhd.: 1 (https://510kreport.com/company/perusahaan-getah-asas-sdn-bhd)

## Firms that cite its devices most
- Comfort Rubber Gloves Industries Sdn. Bhd.: 2 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Maxter Glove Manufacturing Sdn Bhd: 1 (https://510kreport.com/company/maxter-glove-manufacturing-sdn-bhd)
- Brightway Holdings Sdn. Bhd.: 1 (https://510kreport.com/company/brightway-holdings-sdn-bhd)
- Semperit Investments Asia Pte, Ltd.: 1 (https://510kreport.com/company/semperit-investments-asia)
- Zhonghong Pulin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/zhonghong-pulin-medical-products)
- Medical Glove Co., Ltd.: 1 (https://510kreport.com/company/medical-glove)

## Its most-cited devices
- K151750: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (2016), cited by 3
- 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 (2019), cited by 3
- K143131: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (2015), cited by 1
- 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 (2016), cited by 1

## Recent decisions
- K260794: NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR (Aug 18, 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 (Jan 13, 2026)
- 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 (Nov 14, 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) (Jun 13, 2023)
- K191800: Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim (Sep 16, 2019)
- K190606: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (May 28, 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 (Apr 5, 2019)
- K181857: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Nov 20, 2018)

Source page: https://510kreport.com/company/kossan-international-sdn-bhd