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FDA 510(k)

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs

K-Number: K213910 · 2022-03-10

ApplicantChangzhou Universal Medical Equipment Co., Ltd.
Decision Date2022-03-10
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs is a medical device manufactured by Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under approval number K213910. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K213910.

When was Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs approved by the FDA?

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-03-10, under approval number K213910.

What company makes Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs is manufactured by Changzhou Universal Medical Equipment Co., Ltd..

What is the FDA product code for Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs?

The FDA product code for Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs is LZC.

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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 Changzhou Universal Medical Equipment Co., Ltd.

K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) K210145Nitrile Glove Powder Free Blue

Related Devices (Code: LZC)

K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health K151390Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy DrugsMaxter Glove Manufacturing Sdn Bhd K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy DrugsGmp Medicare Sdn Bhd (F25) K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy DrugsCentral Medicare Sdn Bhd K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) 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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