Decision Date2021-10-28
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Nitrile Examination Gloves (Powder free, Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Leping Shengde Medical Technology Company Limited. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211581. 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 Disposable Nitrile Examination Gloves (Powder free, Blue)?
Disposable Nitrile Examination Gloves (Powder free, Blue) is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Leping Shengde Medical Technology Company Limited. The 510(k) number is K211581.
When did Disposable Nitrile Examination Gloves (Powder free, Blue) receive FDA 510(k) clearance?
Disposable Nitrile Examination Gloves (Powder free, Blue) received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211581.
Who is the listed applicant for Disposable Nitrile Examination Gloves (Powder free, Blue)?
The FDA 510(k) record lists Leping Shengde Medical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue)?
The FDA product code for Disposable Nitrile Examination Gloves (Powder free, Blue) is LZA.
Related Clinical Trials
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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.