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FDA 510(k)

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)

K-Number: K211608 · 2021-08-05

ApplicantJiangsu Cureguard Glove Co., Ltd.
Decision Date2021-08-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is a medical device manufactured by Jiangsu Cureguard Glove Co., Ltd.. It received FDA 510(k) clearance on 2021-08-05 under approval number K211608. 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 Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Jiangsu Cureguard Glove Co., Ltd.. The 510(k) number is K211608.

When was Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) approved by the FDA?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-08-05, under approval number K211608.

What company makes Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is manufactured by Jiangsu Cureguard Glove Co., Ltd..

What is the FDA product code for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy 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: 41448934 [Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 41343216 Describing Inconsistencies in Pediatric Labeling of Medical Devices. JAMA network open (2025)

Other Devices by Jiangsu Cureguard Glove Co., Ltd.

K211354Disposable Synthetic Vinyl Nitrile Examination Glove K210691Disposable Nitrile Medical Examination Glove K210684Disposable Nitrile Medical Examination Glove K222937Disposable Nitrile Examination Glove K213121Disposable Nitrile Examination Glove

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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