Surgical Mask
K-Number: K212344 · 2021-11-16
Decision Date2021-11-16
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask is a medical device manufactured by Xiantao Dingcheng Non-Woven Product Co., Ltd.. It received FDA 510(k) clearance on 2021-11-16 under approval number K212344. 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 Surgical Mask?
Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-11-16. It is manufactured by Xiantao Dingcheng Non-Woven Product Co., Ltd.. The 510(k) number is K212344.
When was Surgical Mask approved by the FDA?
Surgical Mask received FDA 510(k) clearance on 2021-11-16, under approval number K212344.
What company makes Surgical Mask?
Surgical Mask is manufactured by Xiantao Dingcheng Non-Woven Product Co., Ltd..
What is the FDA product code for Surgical Mask?
The FDA product code for Surgical Mask is FXX.
Other Devices by Xiantao Dingcheng Non-Woven Product Co., Ltd.
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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.