Surgical Face Mask
K-Number: K212526 · 2021-11-09
Decision Date2021-11-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Suzhou Janee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-09 under approval number K212526. 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 2021-11-09. It is manufactured by Suzhou Janee Medical Technology Co., Ltd.. The 510(k) number is K212526.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2021-11-09, under approval number K212526.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Suzhou Janee Medical Technology Co., Ltd..
What is the FDA product code for Surgical Face Mask?
The FDA product code for Surgical Face Mask is FXX.
Other Devices by Suzhou Janee Medical Technology 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.