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FDA 510(k)

Disposable Medical Face Mask (M643BE)

K-Number: K240258 · 2024-04-18

ApplicantMakrite Industries, Inc.
Decision Date2024-04-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask (M643BE) is a medical device manufactured by Makrite Industries, Inc.. It received FDA 510(k) clearance on 2024-04-18 under approval number K240258. 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 Disposable Medical Face Mask (M643BE)?

Disposable Medical Face Mask (M643BE) is a medical device that received FDA 510(k) clearance on 2024-04-18. It is manufactured by Makrite Industries, Inc.. The 510(k) number is K240258.

When was Disposable Medical Face Mask (M643BE) approved by the FDA?

Disposable Medical Face Mask (M643BE) received FDA 510(k) clearance on 2024-04-18, under approval number K240258.

What company makes Disposable Medical Face Mask (M643BE)?

Disposable Medical Face Mask (M643BE) is manufactured by Makrite Industries, Inc..

What is the FDA product code for Disposable Medical Face Mask (M643BE)?

The FDA product code for Disposable Medical Face Mask (M643BE) is FXX.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by Makrite Industries, Inc.

K220550Disposable Surgical Face Mask (M663BE, M663BT) K252650Disposable Medical Face Mask

Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

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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