Surgical Face Mask
K-Number: K212610 · 2022-01-26
ApplicantFoshan Nanhai Plus Medical Co, Ltd.
Decision Date2022-01-26
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-01-26 under approval number K212610. 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 2022-01-26. It is manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K212610.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2022-01-26, under approval number K212610.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Foshan Nanhai Plus Medical Co, Ltd..
What is the FDA product code for Surgical Face Mask?
The FDA product code for Surgical Face Mask is FXX.
Other Devices by Foshan Nanhai Plus Medical 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.