Penta Glove
K-Number: K212847 · 2022-01-06
ApplicantPentavest Holdings Sdn Bhd
Decision Date2022-01-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Penta Glove is a medical device manufactured by Pentavest Holdings Sdn Bhd. It received FDA 510(k) clearance on 2022-01-06 under approval number K212847. 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 Penta Glove?
Penta Glove is a medical device that received FDA 510(k) clearance on 2022-01-06. It is manufactured by Pentavest Holdings Sdn Bhd. The 510(k) number is K212847.
When was Penta Glove approved by the FDA?
Penta Glove received FDA 510(k) clearance on 2022-01-06, under approval number K212847.
What company makes Penta Glove?
Penta Glove is manufactured by Pentavest Holdings Sdn Bhd.
What is the FDA product code for Penta Glove?
The FDA product code for Penta Glove 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.