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FDA 510(k)

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

K-Number: K230395 · 2023-07-17

ApplicantDurio Ppe Sdn Bhd
Decision Date2023-07-17
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is a medical device manufactured by Durio Ppe Sdn Bhd. It received FDA 510(k) clearance on 2023-07-17 under approval number K230395. 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 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. It is manufactured by Durio Ppe Sdn Bhd. The 510(k) number is K230395.

When was Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) approved by the FDA?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance on 2023-07-17, under approval number K230395.

What company makes 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 manufactured by Durio Ppe Sdn Bhd.

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.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Related Devices (Code: 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.

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