Disposable Surgical Mask
K-Number: K203756 · 2021-06-10
Decision Date2021-06-10
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Mask is a medical device manufactured by Lucky Textile Industrial(Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2021-06-10 under approval number K203756. 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 2021-06-10. It is manufactured by Lucky Textile Industrial(Wuxi) Co., Ltd.. The 510(k) number is K203756.
When was Disposable Surgical Mask approved by the FDA?
Disposable Surgical Mask received FDA 510(k) clearance on 2021-06-10, under approval number K203756.
What company makes Disposable Surgical Mask?
Disposable Surgical Mask is manufactured by Lucky Textile Industrial(Wuxi) Co., Ltd..
What is the FDA product code for Disposable Surgical Mask?
The FDA product code for Disposable Surgical Mask is FXX.
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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.