Decision Date2016-03-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color is the device name listed in this FDA 510(k) record. The listed applicant is Xingda Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K152720. 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 Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color?
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Xingda Medical Products Co., Ltd.. The 510(k) number is K152720.
When did Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color receive FDA 510(k) clearance?
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color received FDA 510(k) clearance on 2016-03-10, under 510(k) number K152720.
Who is the listed applicant for Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color?
The FDA 510(k) record lists Xingda Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color?
The FDA product code for Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color is LZA.
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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.