Surgical face mask
K-Number: K203704 · 2021-06-04
Decision Date2021-06-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical face mask is a medical device manufactured by Juntech(Jiaxing)Healthcare Materials Co,.Ltd. It received FDA 510(k) clearance on 2021-06-04 under approval number K203704. 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 2021-06-04. It is manufactured by Juntech(Jiaxing)Healthcare Materials Co,.Ltd. The 510(k) number is K203704.
When was Surgical face mask approved by the FDA?
Surgical face mask received FDA 510(k) clearance on 2021-06-04, under approval number K203704.
What company makes Surgical face mask?
Surgical face mask is manufactured by Juntech(Jiaxing)Healthcare Materials 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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K152197Skypro, SP01 MaskSkypro Medical Supplies Company
K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd.
K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech
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.