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FDA 510(k)

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)

K-Number: K233990 · 2024-04-01

ApplicantShandong Xingyu Gloves Co., Ltd.
Decision Date2024-04-01
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is a medical device manufactured by Shandong Xingyu Gloves Co., Ltd.. It received FDA 510(k) clearance on 2024-04-01 under approval number K233990. 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 Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is a medical device that received FDA 510(k) clearance on 2024-04-01. It is manufactured by Shandong Xingyu Gloves Co., Ltd.. The 510(k) number is K233990.

When was Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) approved by the FDA?

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) received FDA 510(k) clearance on 2024-04-01, under approval number K233990.

What company makes Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is manufactured by Shandong Xingyu Gloves Co., Ltd..

What is the FDA product code for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

The FDA product code for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is LZA.

Related Clinical Trials

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Shandong Xingyu Gloves Co., Ltd.

K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White color K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color K221272Medical Face Mask

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

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

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