Decision Date2001-08-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE 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 2001-08-16 under 510(k) number K012048. 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 NEOPRENE EXAMINATION GLOVES, NON STERILE?
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K012048.
When did POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE receive FDA 510(k) clearance?
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE received FDA 510(k) clearance on 2001-08-16, under 510(k) number K012048.
Who is the listed applicant for POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE?
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 NEOPRENE EXAMINATION GLOVES, NON STERILE?
The FDA product code for POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE 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.