Disposable Surgical Mask
K-Number: K201893 · 2020-12-09
Decision Date2020-12-09
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Mask is a medical device manufactured by Xiamen Probtain Medical Techology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under approval number K201893. 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 2020-12-09. It is manufactured by Xiamen Probtain Medical Techology Co., Ltd.. The 510(k) number is K201893.
When was Disposable Surgical Mask approved by the FDA?
Disposable Surgical Mask received FDA 510(k) clearance on 2020-12-09, under approval number K201893.
What company makes Disposable Surgical Mask?
Disposable Surgical Mask is manufactured by Xiamen Probtain Medical Techology Co., Ltd..
What is the FDA product code for Disposable Surgical Mask?
The FDA product code for Disposable Surgical Mask is FXX.
Other Devices by Xiamen Probtain Medical Techology Co., Ltd.
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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.