Disposable Surgical Face Mask
K-Number: K212649 · 2022-10-25
Decision Date2022-10-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Face Mask is a medical device manufactured by Lyncmed Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2022-10-25 under approval number K212649. 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 2022-10-25. It is manufactured by Lyncmed Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K212649.
When was Disposable Surgical Face Mask approved by the FDA?
Disposable Surgical Face Mask received FDA 510(k) clearance on 2022-10-25, under approval number K212649.
What company makes Disposable Surgical Face Mask?
Disposable Surgical Face Mask is manufactured by Lyncmed Medical Technology (Beijing) Co., Ltd..
What is the FDA product code for Disposable Surgical Face Mask?
The FDA product code for Disposable Surgical Face Mask is FXX.
Other Devices by Lyncmed Medical Technology (Beijing) Co., Ltd.
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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.