Decision Date1999-11-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED is the device name listed in this FDA 510(k) record. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. It received FDA 510(k) clearance on 1999-11-17 under 510(k) number K992678. 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 PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED?
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED is a medical device that received FDA 510(k) clearance on 1999-11-17. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. The 510(k) number is K992678.
When did PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED receive FDA 510(k) clearance?
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED received FDA 510(k) clearance on 1999-11-17, under 510(k) number K992678.
Who is the listed applicant for PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED?
The FDA 510(k) record lists Wear Safe Malaysia Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED?
The FDA product code for PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED is LZA.
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Other records listing Wear Safe Malaysia Sdn. Bhd. as applicant
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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.