Surgical Face Mask
K-Number: K212059 · 2021-12-17
Decision Date2021-12-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Zhongshan Saifute Labor Protective Articles Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under approval number K212059. 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 2021-12-17. It is manufactured by Zhongshan Saifute Labor Protective Articles Co., Ltd.. The 510(k) number is K212059.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2021-12-17, under approval number K212059.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Zhongshan Saifute Labor Protective Articles 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.
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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.