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FDA 510(k)

Medical nitrile examination gloves (Model: SH001)

K-Number: K213600 · 2022-02-19

Decision Date2022-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Medical nitrile examination gloves (Model: SH001) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Sanhao Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K213600. 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 Medical nitrile examination gloves (Model: SH001)?

Medical nitrile examination gloves (Model: SH001) is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Jiangxi Sanhao Medical Instruments Co.,Ltd. The 510(k) number is K213600.

When did Medical nitrile examination gloves (Model: SH001) receive FDA 510(k) clearance?

Medical nitrile examination gloves (Model: SH001) received FDA 510(k) clearance on 2022-02-19, under 510(k) number K213600.

Who is the listed applicant for Medical nitrile examination gloves (Model: SH001)?

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

What is the FDA product code for Medical nitrile examination gloves (Model: SH001)?

The FDA product code for Medical nitrile examination gloves (Model: SH001) is LZA.

Other records listing Jiangxi Sanhao Medical Instruments 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.

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.