Decision Date2001-01-26
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2001-01-26 under 510(k) number K010072. 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 PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE?
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE is a medical device that received FDA 510(k) clearance on 2001-01-26. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K010072.
When did POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE receive FDA 510(k) clearance?
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE received FDA 510(k) clearance on 2001-01-26, under 510(k) number K010072.
Who is the listed applicant for POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE?
The FDA 510(k) record lists Wrp Asia Pacific Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE?
The FDA product code for POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE is LZA.
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Related Devices (Code: 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.