Surgical Masks
K-Number: K212120 · 2022-01-28
ApplicantHubei Xinxin Non-Woven Co., Ltd.
Decision Date2022-01-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Masks is a medical device manufactured by Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under approval number K212120. 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 Masks?
Surgical Masks is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K212120.
When was Surgical Masks approved by the FDA?
Surgical Masks received FDA 510(k) clearance on 2022-01-28, under approval number K212120.
What company makes Surgical Masks?
Surgical Masks is manufactured by Hubei Xinxin Non-Woven Co., Ltd..
What is the FDA product code for Surgical Masks?
The FDA product code for Surgical Masks is FXX.
Other Devices by Hubei Xinxin Non-Woven 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.