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FDA 510(k)

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

K-Number: K210414 · 2022-10-21

ApplicantMedtecs (Taiwan) Corp.
Decision Date2022-10-21
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is a medical device manufactured by Medtecs (Taiwan) Corp.. It received FDA 510(k) clearance on 2022-10-21 under approval number K210414. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Medtecs (Taiwan) Corp.. The 510(k) number is K210414.

When was CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown approved by the FDA?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown received FDA 510(k) clearance on 2022-10-21, under approval number K210414.

What company makes CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is manufactured by Medtecs (Taiwan) Corp..

What is the FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

The FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is FYC.

Related Clinical Trials

NCT07508332 Lung Boost Trainer Versus Incentive Spirometer in Post COVID-19 Hemiplegic CP Children COMPLETED

Other Devices by Medtecs (Taiwan) Corp.

K203376ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

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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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