# Koon Seng Sdn Bhd

- Location (FDA's records): Greenwood Village, CO
- FDA decisions: 7 (1989–2021): 7 510(k) clearances
- Product codes: LYY (4), LZA (3)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (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
- Ultrawin Sdn Bhd: 1 (https://510kreport.com/company/ultrawin-sdn-bhd)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Sgmp Co., Ltd.: 1 (https://510kreport.com/company/sgmp)
- Pt. Maja Agung Latexindo: 1 (https://510kreport.com/company/pt-maja-agung-latexindo)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)

## Firms that cite its devices most
- Ever Global (Vietnam) Enterprise Corporation: 1 (https://510kreport.com/company/ever-global-vietnam-enterprise)

## Its most-cited devices
- K171171: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (2018), cited by 1

## Recent decisions
- K212613: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) (Dec 21, 2021)
- K171171: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (Feb 22, 2018)
- K110960: Royal Imperial Nitrile Examination Gloves Textured Powder-Free (Jul 14, 2011)
- K093375: KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less) (Dec 2, 2009)
- K013537: Royal Imperial Powdered Latex Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less) (Dec 7, 2001)
- K012714: Royal Imperial Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or (Oct 31, 2001)
- K891821: Patient Examination Gloves (Latex) (May 31, 1989)

Source page: https://510kreport.com/company/koon-seng-sdn-bhd