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FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

K-Number: K211667 · 2021-09-23

ApplicantChangzhou Universal Medical Equipment Co., Ltd.
Decision Date2021-09-23
Product CodeLAZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device manufactured by Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under approval number K211667. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K211667.

When was Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) approved by the FDA?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-09-23, under approval number K211667.

What company makes Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is manufactured by Changzhou Universal Medical Equipment Co., Ltd..

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is LAZ.

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Related PubMed Literature

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Other Devices by Changzhou Universal Medical Equipment Co., Ltd.

K210145Nitrile Glove Powder Free Blue K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs

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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