Disposable Surgical Face Mask
K-Number: K153496 · 2016-06-15
Decision Date2016-06-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Face Mask is a medical device manufactured by Xiantao Rayxin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2016-06-15 under approval number K153496. 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 2016-06-15. It is manufactured by Xiantao Rayxin Medical Products Co., Ltd.. The 510(k) number is K153496.
When was Disposable Surgical Face Mask approved by the FDA?
Disposable Surgical Face Mask received FDA 510(k) clearance on 2016-06-15, under approval number K153496.
What company makes Disposable Surgical Face Mask?
Disposable Surgical Face Mask is manufactured by Xiantao Rayxin Medical Products 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 Xiantao Rayxin Medical Products Co., Ltd.
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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.