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FDA 510(k)

Disposable Medical Nitrile Examination Gloves (Model:XYS-001)

K-Number: K213371 · 2021-12-09

ApplicantAnhui Xinyisheng Medical Technology Co.,Ltd
Decision Date2021-12-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves (Model:XYS-001) is a medical device manufactured by Anhui Xinyisheng Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-12-09 under approval number K213371. 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 Disposable Medical Nitrile Examination Gloves (Model:XYS-001)?

Disposable Medical Nitrile Examination Gloves (Model:XYS-001) is a medical device that received FDA 510(k) clearance on 2021-12-09. It is manufactured by Anhui Xinyisheng Medical Technology Co.,Ltd. The 510(k) number is K213371.

When was Disposable Medical Nitrile Examination Gloves (Model:XYS-001) approved by the FDA?

Disposable Medical Nitrile Examination Gloves (Model:XYS-001) received FDA 510(k) clearance on 2021-12-09, under approval number K213371.

What company makes Disposable Medical Nitrile Examination Gloves (Model:XYS-001)?

Disposable Medical Nitrile Examination Gloves (Model:XYS-001) is manufactured by Anhui Xinyisheng Medical Technology Co.,Ltd.

What is the FDA product code for Disposable Medical Nitrile Examination Gloves (Model:XYS-001)?

The FDA product code for Disposable Medical Nitrile Examination Gloves (Model:XYS-001) is LZA.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026)

Other Devices by Anhui Xinyisheng Medical Technology Co.,Ltd

K213325Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy 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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