FDA 510(k)

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)

K-Number: K240824 · 2024-06-25

ApplicantNingxia Qiaoen Medical Technology Co., Ltd.

Decision Date2024-06-25

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is the device name listed in this FDA 510(k) record. The listed applicant is Ningxia Qiaoen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-25 under 510(k) number K240824. 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 (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Ningxia Qiaoen Medical Technology Co., Ltd.. The 510(k) number is K240824.

When did Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) received FDA 510(k) clearance on 2024-06-25, under 510(k) number K240824.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

The FDA 510(k) record lists Ningxia Qiaoen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)?

The FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) is LZA.

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Official Source

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