Decision Date2019-01-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Powder Free Nitrile Patient Examination Gloves, Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Dongxin Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K181106. 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 Powder Free Nitrile Patient Examination Gloves, Blue Color?
Powder Free Nitrile Patient Examination Gloves, Blue Color is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Jiangsu Dongxin Medical Technology Co., Ltd.. The 510(k) number is K181106.
When did Powder Free Nitrile Patient Examination Gloves, Blue Color receive FDA 510(k) clearance?
Powder Free Nitrile Patient Examination Gloves, Blue Color received FDA 510(k) clearance on 2019-01-16, under 510(k) number K181106.
Who is the listed applicant for Powder Free Nitrile Patient Examination Gloves, Blue Color?
The FDA 510(k) record lists Jiangsu Dongxin Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color?
The FDA product code for Powder Free Nitrile Patient Examination Gloves, Blue Color is LZA.
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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.