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FDA 510(k)

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

K-Number: K230662 · 2023-10-26

ApplicantZhonghong Pulin Medical Products Co., Ltd.
Decision Date2023-10-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is a medical device manufactured by Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K230662. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K230662.

When was Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs approved by the FDA?

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs received FDA 510(k) clearance on 2023-10-26, under approval number K230662.

What company makes Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is manufactured by Zhonghong Pulin Medical Products Co., Ltd..

What is the FDA product code for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

The FDA product code for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is LZA.

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Related PubMed Literature

PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 40606638 Silent protocol modifications in multiple sclerosis clinical trials: a registry-based cross-sectional study. Therapeutic advances in neurological disorders (2025) PMID: 39958972 A critical opinion-based review of hospital pharmacy compounding with respect to the risk of leachable substances due to the off-label use of plastic primary packaging. Therapeutic advances in drug safety (2025)

Other Devices by Zhonghong Pulin Medical Products Co., Ltd.

K152712Nitrile Powder Free Patient Examination Gloves, Blue Color K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs K210460NitriTec Vinyl Glove Powder Free Blue K231029Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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