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FDA 510(k)

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl

K-Number: K231029 · 2023-10-30

ApplicantZhonghong Pulin Medical Products Co., Ltd.
Decision Date2023-10-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl is a medical device manufactured by Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-10-30 under approval number K231029. 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, Tested For Use With Chemotherapy Drugs And Fentanyl?

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl is a medical device that received FDA 510(k) clearance on 2023-10-30. It is manufactured by Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K231029.

When was Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl approved by the FDA?

Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl received FDA 510(k) clearance on 2023-10-30, under approval number K231029.

What company makes Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl?

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

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

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

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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 K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs

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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