Decision Date2021-10-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K210706. 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?
Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Niujian Technology Co., Ltd.. The 510(k) number is K210706.
When did Nitrile Examination Gloves receive FDA 510(k) clearance?
Nitrile Examination Gloves received FDA 510(k) clearance on 2021-10-19, under 510(k) number K210706.
Who is the listed applicant for Nitrile Examination Gloves?
The FDA 510(k) record lists Niujian 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?
The FDA product code for Nitrile Examination Gloves is LZA.
Related Clinical Trials
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.
Other records listing Niujian 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.
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.
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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.