Disposable Surgical Face Mask
K-Number: K203685 · 2021-03-26
Decision Date2021-03-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Face Mask is a medical device manufactured by Xiantao Zhongyi Safety & Protection Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under approval number K203685. 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 Disposable Surgical Face Mask?
Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Xiantao Zhongyi Safety & Protection Products Co., Ltd.. The 510(k) number is K203685.
When was Disposable Surgical Face Mask approved by the FDA?
Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-03-26, under approval number K203685.
What company makes Disposable Surgical Face Mask?
Disposable Surgical Face Mask is manufactured by Xiantao Zhongyi Safety & Protection Products Co., Ltd..
What is the FDA product code for Disposable Surgical Face Mask?
The FDA product code for Disposable Surgical Face Mask is FXX.
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K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
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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.