Disposable Surgical Mask
K-Number: K210372 · 2021-06-07
Decision Date2021-06-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Mask is a medical device manufactured by Dongguan Shin YI Healthcare Products Factory. It received FDA 510(k) clearance on 2021-06-07 under approval number K210372. 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 Mask?
Disposable Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-06-07. It is manufactured by Dongguan Shin YI Healthcare Products Factory. The 510(k) number is K210372.
When was Disposable Surgical Mask approved by the FDA?
Disposable Surgical Mask received FDA 510(k) clearance on 2021-06-07, under approval number K210372.
What company makes Disposable Surgical Mask?
Disposable Surgical Mask is manufactured by Dongguan Shin YI Healthcare Products Factory.
What is the FDA product code for Disposable Surgical Mask?
The FDA product code for Disposable Surgical Mask is FXX.
Other Devices by Dongguan Shin YI Healthcare Products Factory
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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.