Medical Face Masks
K-Number: K202627 · 2021-02-03
Decision Date2021-02-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Face Masks is a medical device manufactured by Guilin Hbm Sanitary Protections, Inc.. It received FDA 510(k) clearance on 2021-02-03 under approval number K202627. 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 Medical Face Masks?
Medical Face Masks is a medical device that received FDA 510(k) clearance on 2021-02-03. It is manufactured by Guilin Hbm Sanitary Protections, Inc.. The 510(k) number is K202627.
When was Medical Face Masks approved by the FDA?
Medical Face Masks received FDA 510(k) clearance on 2021-02-03, under approval number K202627.
What company makes Medical Face Masks?
Medical Face Masks is manufactured by Guilin Hbm Sanitary Protections, Inc..
What is the FDA product code for Medical Face Masks?
The FDA product code for Medical Face Masks 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.