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FDA 510(k)

Disposable Surgical Gown, Disposable Reinforced Surgical Gown

K-Number: K212869 · 2021-12-13

ApplicantFugou County Shenxiang Manufacturing Co., Ltd.
Decision Date2021-12-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is a medical device manufactured by Fugou County Shenxiang Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under approval number K212869. 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 Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Fugou County Shenxiang Manufacturing Co., Ltd.. The 510(k) number is K212869.

When was Disposable Surgical Gown, Disposable Reinforced Surgical Gown approved by the FDA?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown received FDA 510(k) clearance on 2021-12-13, under approval number K212869.

What company makes Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

Disposable Surgical Gown, Disposable Reinforced Surgical Gown is manufactured by Fugou County Shenxiang Manufacturing Co., Ltd..

What is the FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown?

The FDA product code for Disposable Surgical Gown, Disposable Reinforced Surgical Gown is 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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