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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is At Glove Engineering Sdn. Bhd. It received FDA 510(k) clearance on 2021-12-16 under 510(k) 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. The listed applicant is At Glove Engineering Sdn. Bhd. The 510(k) number is K212645.

When did AT receive FDA 510(k) clearance?

AT received FDA 510(k) clearance on 2021-12-16, under 510(k) number K212645.

Who is the listed applicant for AT?

The FDA 510(k) record lists At Glove Engineering Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AT?

The FDA product code for AT is LZA.

Related Devices (Code: LZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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