# Better Care Plastic Technology Co., Ltd.

- Location (FDA's records): Shenze County, CN
- FDA decisions: 11 (2014–2025): 11 510(k) clearances
- Product codes: LZA (8), KGO (2), LZC (1)
- 510(k) review time since 2016: median 89 days, against 101 for FDA's reviews in the same codes and years (6 of 10 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 13 (3 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
- Comfort Rubber Gloves Industries Sdn. Bhd.: 2 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Hartalega NGC Sdn. Bhd.: 2 (https://510kreport.com/company/hartalega-ngc-sdn-bhd)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)
- Central Medicare Sdn Bhd: 1 (https://510kreport.com/company/central-medicare-sdn-bhd)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)
- Syntex Healthcare Products Co., Ltd.: 1 (https://510kreport.com/company/syntex-healthcare-products)

## Firms that cite its devices most
- Shanxi Hongjin Plastic Technology Co., Ltd.: 1 (https://510kreport.com/company/shanxi-hongjin-plastic-technology)
- Iconic Medicare Sdn Bhd: 1 (https://510kreport.com/company/iconic-medicare-sdn-bhd)
- Guilin Hbm Health Protections, Inc.: 1 (https://510kreport.com/company/guilin-hbm-health-protections)
- Lingshi Hongruida Health Protection Technology Co., Ltd.: 1 (https://510kreport.com/company/lingshi-hongruida-health-protection-technology)
- Puyang Linshi Medical Supplies Co., Ltd.: 1 (https://510kreport.com/company/puyang-linshi-medical-supplies)
- Anhui Intco Medical Products Co., Ltd.: 1 (https://510kreport.com/company/anhui-intco-medical-products)
- Xingyu Medical Tech Co., Ltd.: 1 (https://510kreport.com/company/xingyu-medical-tech)
- Harbour Health, LLC: 1 (https://510kreport.com/company/harbour-health)

## Its most-cited devices
- K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2022), cited by 4
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), cited by 3
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2018), cited by 3
- K171047: Sterile Polyisoprene Powder Free Surgical Gloves (2017), cited by 2
- K223713: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), cited by 1

## Recent decisions
- K242533: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Mar 18, 2025)
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Nov 3, 2023)
- K232070: Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) (Oct 11, 2023)
- K231567: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) (Oct 4, 2023)
- K223713: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Aug 7, 2023)
- K222449: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) (Aug 27, 2022)
- K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Jul 27, 2022)
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (Nov 30, 2018)

Source page: https://510kreport.com/company/better-care-plastic-technology