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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 the device name listed in this FDA 510(k) record. The listed applicant is Makrite Industries, Inc.. It received FDA 510(k) clearance on 2024-04-18 under 510(k) 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. The listed applicant is Makrite Industries, Inc.. The 510(k) number is K240258.

When did Disposable Medical Face Mask (M643BE) receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Medical Face Mask (M643BE)?

The FDA 510(k) record lists Makrite Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Makrite Industries, Inc. as applicant

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.

K252650Disposable Medical Face MaskK220550Disposable Surgical Face Mask (M663BE, M663BT)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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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