Surgical Mask
K-Number: K211255 · 2021-08-28
Decision Date2021-08-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask is a medical device manufactured by Tianchang Kanghui Protective Products Co, Ltd.. It received FDA 510(k) clearance on 2021-08-28 under approval number K211255. 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 2021-08-28. It is manufactured by Tianchang Kanghui Protective Products Co, Ltd.. The 510(k) number is K211255.
When was Surgical Mask approved by the FDA?
Surgical Mask received FDA 510(k) clearance on 2021-08-28, under approval number K211255.
What company makes Surgical Mask?
Surgical Mask is manufactured by Tianchang Kanghui Protective Products Co, Ltd..
What is the FDA product code for Surgical Mask?
The FDA product code for Surgical Mask is FXX.
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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.