FDA.reportPublic FDA data

Makrite Industries Inc.

Primary DI
06973875280775
Brand
Makrite Industries Inc.
Company
Makrite Hubei Industrial Co., Ltd.
Model
M663BE
Device description
FDA cleared ASTM Level 3 earloop surgical face mask, regular size.
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220550000Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc.2022-06-14FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973875280772PackageGS140In Commercial Distribution
06973875280775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697387528077216973875280772
06973875280775069738752807756973875280775

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
553815471
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973875280027Makrite Industries Inc.9500-N952023-07-06
06973875280065Makrite Industries Inc.9500-N95S2023-07-14
06973875280744Makrite Industries Inc.FIT+48032023-07-21
06973875280751Makrite Industries Inc.96032023-07-21
06973875280768Makrite Industries Inc.9603S2023-07-21
06973875280072Makrite Industries Inc.910-N95FMX2023-07-14
06973875280089Makrite Industries Inc.Sekura-X2022-06-17
16973875280741Makrite Industries Inc.FIT+48032023-07-21
16973875280758Makrite Industries Inc.96032023-07-21
16973875280765Makrite Industries Inc.9603S2023-07-21
06973875280782Makrite Industries Inc.M663BT2023-07-14
06973875281017Makrite Industries Inc.9500-N95S2023-07-14
16973875280789Makrite Industries Inc.M663BT2023-07-14
06973875281000Makrite Industries Inc.9500-N952023-07-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
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