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FDA 510(k)

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

K-Number: K221027 · 2022-08-12

ApplicantAllmed Medical (Hubei) Protective Products Co., Ltd.
Decision Date2022-08-12
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is a medical device manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-08-12 under approval number K221027. 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 Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd.. The 510(k) number is K221027.

When was Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) approved by the FDA?

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) received FDA 510(k) clearance on 2022-08-12, under approval number K221027.

What company makes Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd..

What is the FDA product code for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))?

The FDA product code for Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) is FYC.

Other Devices by Allmed Medical (Hubei) Protective Products Co., Ltd.

K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)

Related Devices (Code: FYC)

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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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