Surgical Mask
K-Number: K202191 · 2021-03-29
Decision Date2021-03-29
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask is a medical device manufactured by Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-29 under approval number K202191. 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 2021-03-29. It is manufactured by Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K202191.
When was Surgical Mask approved by the FDA?
Surgical Mask received FDA 510(k) clearance on 2021-03-29, under approval number K202191.
What company makes Surgical Mask?
Surgical Mask is manufactured by Wuhan Zonsen Medical Products Co., Ltd..
What is the FDA product code for Surgical Mask?
The FDA product code for Surgical Mask is FXX.
Other Devices by Wuhan Zonsen Medical Products Co., Ltd.
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K152197Skypro, SP01 MaskSkypro Medical Supplies Company
K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , 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.