Surgical Masks
K-Number: K203524 · 2021-02-25
Decision Date2021-02-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Masks is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under approval number K203524. 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 Masks?
Surgical Masks is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K203524.
When was Surgical Masks approved by the FDA?
Surgical Masks received FDA 510(k) clearance on 2021-02-25, under approval number K203524.
What company makes Surgical Masks?
Surgical Masks is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..
What is the FDA product code for Surgical Masks?
The FDA product code for Surgical Masks is FXX.
Other Devices by Bain Medical Equipment (Guangzhou) Co., Ltd.
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K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., 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.