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FDA 510(k)

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K-Number: K233042 · 2023-12-06

ApplicantShandong Intco Medical Products Co, Ltd.
Decision Date2023-12-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device manufactured by Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-12-06 under approval number K233042. 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 Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K233042.

When was Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate approved by the FDA?

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2023-12-06, under approval number K233042.

What company makes Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is manufactured by Shandong Intco Medical Products Co, Ltd..

What is the FDA product code for Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 Intco Medical Products Co, Ltd.

K213509Latex Examination Gloves, Powder Free K231408Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

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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