# Comfort Rubber Gloves Industries Sdn. Bhd.

- Location (FDA's records): Matang, MY
- FDA decisions: 15 (1994–2025): 15 510(k) clearances
- Product codes: LZA (8), LYY (6), LZC (1)
- 510(k) review time since 2016: median 140 days, against 103 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 14 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kossan International Sdn Bhd: 2 (https://510kreport.com/company/kossan-international-sdn-bhd)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)
- Top Glove Sdn. Bhd.: 1 (https://510kreport.com/company/top-glove-sdn-bhd)
- Wrp Rubber Products Sdn Bhd: 1 (https://510kreport.com/company/wrp-rubber-products-sdn-bhd)
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.: 1 (https://510kreport.com/company/jr-engineering-medical-technologies-m-sdn-bhd)
- Hartalega NGC Sdn. Bhd.: 1 (https://510kreport.com/company/hartalega-ngc-sdn-bhd)

## Firms that cite its devices most
- Better Care Plastic Technology Co., Ltd.: 2 (https://510kreport.com/company/better-care-plastic-technology)
- Koon Seng Sdn Bhd: 1 (https://510kreport.com/company/koon-seng-sdn-bhd)
- Encompass Industries Sdn. Bhd.: 1 (https://510kreport.com/company/encompass-industries-sdn-bhd)
- Meditech Gloves Sdn Bhd: 1 (https://510kreport.com/company/meditech-gloves-sdn-bhd)
- Riverstone Resources Sdn Bhd: 1 (https://510kreport.com/company/riverstone-resources-sdn-bhd)
- Rmkh Glove (Cambodia) Co., Ltd.: 1 (https://510kreport.com/company/rmkh-glove-cambodia)
- Mah Sing Healthcare Sdn. Bhd.: 1 (https://510kreport.com/company/mah-sing-healthcare-sdn-bhd)
- Genabio Diagnostics, Inc.: 1 (https://510kreport.com/company/genabio-diagnostics)

## Its most-cited devices
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (2020), cited by 11
- K162405: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) (2017), cited by 1
- K200181: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2020), cited by 1
- K180476: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), cited by 1

## Recent decisions
- K250069: Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (Apr 29, 2025)
- K240269: Nitrile Powder Free Examination Gloves Biodegradable (Green) (Oct 25, 2024)
- K241528: Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (Aug 6, 2024)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (Jun 19, 2020)
- K200181: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Apr 15, 2020)
- K190080: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) (Jun 27, 2019)
- K180476: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (May 15, 2018)
- K171541: Powder Free Nitrile Examination Gloves (Orange) (Sep 20, 2017)

Source page: https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd