AT
K-Number: K212645 · 2021-12-16
ApplicantAt Glove Engineering Sdn. Bhd
Decision Date2021-12-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
AT is a medical device manufactured by At Glove Engineering Sdn. Bhd. It received FDA 510(k) clearance on 2021-12-16 under approval number K212645. 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 AT?
AT is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by At Glove Engineering Sdn. Bhd. The 510(k) number is K212645.
When was AT approved by the FDA?
AT received FDA 510(k) clearance on 2021-12-16, under approval number K212645.
What company makes AT?
AT is manufactured by At Glove Engineering Sdn. Bhd.
What is the FDA product code for AT?
The FDA product code for AT 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.