Decision Date2009-10-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) 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 2009-10-21 under 510(k) number K092411. 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 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Shen Wei (Usa), Inc.. The 510(k) number is K092411.
When did PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) receive FDA 510(k) clearance?
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092411.
Who is the listed applicant for PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?
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 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)?
The FDA product code for PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) 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.