# Careglove Global Sdn. Bhd.

- Location (FDA's records): Seremban, MY
- FDA decisions: 8 (2017–2025): 8 510(k) clearances
- Product codes: LZA (6), KGO (1), LYY (1)
- 510(k) review time since 2016: median 196 days, against 111 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 8 (1 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
- Careplus (M) Sdn Bhd: 3 (https://510kreport.com/company/careplus-m-sdn-bhd)
- Smart Glove Corp. Sdn Bhd: 1 (https://510kreport.com/company/smart-glove-sdn-bhd)
- Supermax Glove Manufacturing Sdn Bhd: 1 (https://510kreport.com/company/supermax-glove-manufacturing-sdn-bhd)
- Meditech Gloves Sdn Bhd: 1 (https://510kreport.com/company/meditech-gloves-sdn-bhd)

## Firms that cite its devices most
- Iconic Medicare Sdn Bhd: 1 (https://510kreport.com/company/iconic-medicare-sdn-bhd)
- Professional Latex Sdn Bhd: 1 (https://510kreport.com/company/professional-latex-sdn-bhd)
- Tianjin Aoshang Outdoor Equipment Co., Ltd.: 1 (https://510kreport.com/company/tianjin-aoshang-outdoor-equipment)
- Dehai (Shandong) Medical Gloves, Co., Ltd.: 1 (https://510kreport.com/company/dehai-shandong-medical-gloves)
- Edma Group, LLC: 1 (https://510kreport.com/company/edma-group)
- Shandong Intco Medical Products Co, Ltd.: 1 (https://510kreport.com/company/shandong-intco-medical-products)
- Jiangxi Ronglai Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangxi-ronglai-medical-technology)

## Its most-cited devices
- K161833: Latex Examination Glove Powder Free (2017), cited by 3
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored) (2017), cited by 3
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (2023), cited by 2

## Recent decisions
- K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (Apr 1, 2025)
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (May 15, 2023)
- K220859: Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) (Sep 9, 2022)
- K213993: Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (Aug 5, 2022)
- K211666: Powder Free Nitrile Examination Gloves, Blue Chemotest (Jan 9, 2022)
- K190241: Sterile Latex Surgical Glove, Powder Free (Dec 30, 2019)
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored) (Sep 26, 2017)
- K161833: Latex Examination Glove Powder Free (May 23, 2017)

Source page: https://510kreport.com/company/careglove-global-sdn-bhd