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FDA 510(k)

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

K-Number: K212834 · 2021-12-30

ApplicantSiyang Threeguard Medical Supplies Co., Ltd.
Decision Date2021-12-30
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 Siyang Threeguard Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-12-30 under approval number K212834. 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 2021-12-30. It is manufactured by Siyang Threeguard Medical Supplies Co., Ltd.. The 510(k) number is K212834.

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 2021-12-30, under approval number K212834.

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 Siyang Threeguard Medical Supplies 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 Siyang Threeguard Medical Supplies Co., Ltd.

K211131Disposable Nitrile Medical 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

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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