K-number	K210622
Device name	Single-Use Medical Face Mask
Applicant	Jiangxi Hongda Medical Equipment Group Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Oct 8, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Single-Use Medical Face Mask

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