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FDA 510(k)

INTAI Surgical Mask (non-sterile)

K-Number: K210422 · 2022-03-30

ApplicantIntai Technology Corp.
Decision Date2022-03-30
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTAI Surgical Mask (non-sterile) is a medical device manufactured by Intai Technology Corp.. It received FDA 510(k) clearance on 2022-03-30 under approval number K210422. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTAI Surgical Mask (non-sterile)?

INTAI Surgical Mask (non-sterile) is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Intai Technology Corp.. The 510(k) number is K210422.

When was INTAI Surgical Mask (non-sterile) approved by the FDA?

INTAI Surgical Mask (non-sterile) received FDA 510(k) clearance on 2022-03-30, under approval number K210422.

What company makes INTAI Surgical Mask (non-sterile)?

INTAI Surgical Mask (non-sterile) is manufactured by Intai Technology Corp..

What is the FDA product code for INTAI Surgical Mask (non-sterile)?

The FDA product code for INTAI Surgical Mask (non-sterile) is FXX.

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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.

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