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FDA 510(k)

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

K-Number: K221637 · 2022-09-29

ApplicantAllmed Medical (Hubei) Protective Products Co., Ltd.
Decision Date2022-09-29
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is a medical device manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-29 under approval number K221637. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is a medical device that received FDA 510(k) clearance on 2022-09-29. It is manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd.. The 510(k) number is K221637.

When was Surgical Gown (Sterile); Surgical Gown (Non-sterile) approved by the FDA?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) received FDA 510(k) clearance on 2022-09-29, under approval number K221637.

What company makes Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

Surgical Gown (Sterile); Surgical Gown (Non-sterile) is manufactured by Allmed Medical (Hubei) Protective Products Co., Ltd..

What is the FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile)?

The FDA product code for Surgical Gown (Sterile); Surgical Gown (Non-sterile) is FYA.

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

K221027Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

Related Devices (Code: FYA)

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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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