Decision Date2020-06-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Latex Examination Powder Free Glove, Aloe Vera is the device name listed in this FDA 510(k) record. The listed applicant is Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K193150. 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 Latex Examination Powder Free Glove, Aloe Vera?
Latex Examination Powder Free Glove, Aloe Vera is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Top Glove Sdn. Bhd.. The 510(k) number is K193150.
When did Latex Examination Powder Free Glove, Aloe Vera receive FDA 510(k) clearance?
Latex Examination Powder Free Glove, Aloe Vera received FDA 510(k) clearance on 2020-06-05, under 510(k) number K193150.
Who is the listed applicant for Latex Examination Powder Free Glove, Aloe Vera?
The FDA 510(k) record lists Top Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Latex Examination Powder Free Glove, Aloe Vera?
The FDA product code for Latex Examination Powder Free Glove, Aloe Vera 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.