Surgical Mask
K-Number: K213358 · 2022-03-04
Decision Date2022-03-04
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask is a medical device manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. It received FDA 510(k) clearance on 2022-03-04 under approval number K213358. 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 Mask?
Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. The 510(k) number is K213358.
When was Surgical Mask approved by the FDA?
Surgical Mask received FDA 510(k) clearance on 2022-03-04, under approval number K213358.
What company makes Surgical Mask?
Surgical Mask is manufactured by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd..
What is the FDA product code for Surgical Mask?
The FDA product code for Surgical Mask is FXX.
Other Devices by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
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K152197Skypro, SP01 MaskSkypro Medical Supplies Company
K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd.
K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech
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.