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FDA 510(k)

Nitrile Examination Gloves, Dual Color Black-Blue

K-Number: K232550 · 2023-10-20

Decision Date2023-10-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Examination Gloves, Dual Color Black-Blue is the device name listed in this FDA 510(k) record. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232550. 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 Nitrile Examination Gloves, Dual Color Black-Blue?

Nitrile Examination Gloves, Dual Color Black-Blue is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Shanxi Hongjin Plastic Technology Co., Ltd.. The 510(k) number is K232550.

When did Nitrile Examination Gloves, Dual Color Black-Blue receive FDA 510(k) clearance?

Nitrile Examination Gloves, Dual Color Black-Blue received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232550.

Who is the listed applicant for Nitrile Examination Gloves, Dual Color Black-Blue?

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

What is the FDA product code for Nitrile Examination Gloves, Dual Color Black-Blue?

The FDA product code for Nitrile Examination Gloves, Dual Color Black-Blue is LZA.

Other records listing Shanxi Hongjin Plastic 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.