Decision Date2005-03-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei (Usa), Inc.. It received FDA 510(k) clearance on 2005-03-30 under 510(k) number K050467. 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 BUTADIENE EXAM GLOVES WITH ALOE, GREEN?
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K050467.
When did POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN receive FDA 510(k) clearance?
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN received FDA 510(k) clearance on 2005-03-30, under 510(k) number K050467.
Who is the listed applicant for POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN?
The FDA 510(k) record lists Shen Wei (Usa), Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN?
The FDA product code for POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN is LZA.
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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.