Surgical Face Mask
K-Number: K203190 · 2021-06-02
ApplicantRfx+Care Manufactoring Co., Ltd.
Decision Date2021-06-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Rfx+Care Manufactoring Co., Ltd.. It received FDA 510(k) clearance on 2021-06-02 under approval number K203190. 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 2021-06-02. It is manufactured by Rfx+Care Manufactoring Co., Ltd.. The 510(k) number is K203190.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2021-06-02, under approval number K203190.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Rfx+Care Manufactoring 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.