Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
K-Number: K230395 · 2023-07-17
Device Summary
Frequently Asked Questions
What is the Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Durio Ppe Sdn Bhd. The 510(k) number is K230395.
When did Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) receive FDA 510(k) clearance?
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230395.
Who is the listed applicant for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?
The FDA 510(k) record lists Durio Ppe Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?
The FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is FXX.
Related Devices (Code: FXX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.