Surgical Face Mask
K-Number: K202277 · 2020-09-25
Decision Date2020-09-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Face Mask is a medical device manufactured by Jiangxi 3l Medical Products Group Co., Ltd.. It received FDA 510(k) clearance on 2020-09-25 under approval number K202277. 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 2020-09-25. It is manufactured by Jiangxi 3l Medical Products Group Co., Ltd.. The 510(k) number is K202277.
When was Surgical Face Mask approved by the FDA?
Surgical Face Mask received FDA 510(k) clearance on 2020-09-25, under approval number K202277.
What company makes Surgical Face Mask?
Surgical Face Mask is manufactured by Jiangxi 3l Medical Products Group 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.