# Kossan Latex Industries (M)Sdn Bhd

- Location (FDA's records): Klang, Selangor, MY
- FDA decisions: 19 (1989–2013): 19 510(k) clearances
- Product codes: LYY (11), LZA (7), LZC (1)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 6 (2 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
- Perusahaan Getah Asas Sdn. Bhd.: 1 (https://510kreport.com/company/perusahaan-getah-asas-sdn-bhd)

## Firms that cite its devices most
- Wear Safe (Malaysia) Sdn Bhd - Facility II: 1 (https://510kreport.com/company/wear-safe-malaysia-sdn-bhd-facility-ii)
- Northstar Healthcare Holdings: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Ideal Quality Sdn., Bhd.: 1 (https://510kreport.com/company/ideal-quality-sdn-bhd)
- Zhanjiang Jiali Glove Products Co., Ltd.: 1 (https://510kreport.com/company/zhanjiang-jiali-glove-products)

## Its most-cited devices
- K062764: Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored (2007), cited by 2
- K111772: Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile (2011), cited by 1
- K060771: Powder-Free Nitrile Patient Examination Glove,White (Non-Colored) and Blue Colored (2006), cited by 1
- K120066: Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential (2012), cited by 1
- K062965: Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling Claim (2006), cited by 1

## Recent decisions
- K123749: Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile (Mar 1, 2013)
- K120066: Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential (Nov 16, 2012)
- K111772: Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile (Oct 20, 2011)
- K062764: Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored (Feb 27, 2007)
- K062965: Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling Claim (Dec 22, 2006)
- K060775: Powder-Free Latex Patient Examination Glove,with Extractable Protein Content Labelling Claim (50 Microgram Per Gram of (May 16, 2006)
- K060771: Powder-Free Nitrile Patient Examination Glove,White (Non-Colored) and Blue Colored (May 1, 2006)
- K024025: Powder-Free Nitrile Patient Examination Glove, Violet Color (Dec 18, 2002)

Source page: https://510kreport.com/company/kossan-latex-industries-m-sdn-bhd
