K-number	K230395
Device name	Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
Applicant	Durio Ppe Sdn Bhd
Product code	FXX
Device class	Class II
Decision date	Jul 17, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

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