Surgical Face Mask
K-Number: K212863 · 2022-02-19
Decision Date2022-02-19
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2022-02-19 under approval number K212863. 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 Face Mask?
Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-02-19. It is manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd.. The 510(k) number is K212863.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2022-02-19, under approval number K212863.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Taiwan Comfort Champ Manufacturing Co., Ltd..
What is the FDA product code for Surgical Face Mask?
The FDA product code for Surgical Face Mask is FXX.
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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.