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FDA 510(k)

Disposable Medical Nitrile Examination Gloves

K-Number: K223895 · 2023-03-23

Decision Date2023-03-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K223895. 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?

Disposable Medical Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K223895.

When did Disposable Medical Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves received FDA 510(k) clearance on 2023-03-23, under 510(k) number K223895.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves?

The FDA 510(k) record lists Hebei Titans Hongsen 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?

The FDA product code for Disposable Medical Nitrile Examination Gloves is LZA.

Other records listing Hebei Titans Hongsen Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.