FDA.reportPublic FDA data

Top Quality Manufacturing

Primary DI
TQ26180151081
Brand
Top Quality Manufacturing
Company
TOP QUALITY MANUFACTURING, INC.
Model
18015108
Device description
TQMPL - Face Mask - ASTM 3 - Earloop - 4-ply - Blue - 50 / box
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K221222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221222000Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.2022-06-06FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26180151081PrimaryHIBCC0
TQ26180151080Unit of UseHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-8559regulatory@topqualitygloves.com

Regulatory Flags#

DUNS number
113630649
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TQ26126092411Top Quality Manufacturing126092412024-10-30
TQ26126092431Top Quality Manufacturing126092432024-10-28
TQ26126092441Top Quality Manufacturing126092442024-10-28
TQ26126092501Top Quality Manufacturing126092502024-10-28
TQ26126092521Top Quality Manufacturing126092522024-10-28
TQ26126092531Top Quality Manufacturing126092532024-10-28
TQ26126092551Top Quality Manufacturing126092552024-10-28
TQ26126092561Top Quality Manufacturing126092562024-10-28
TQ26126092571Top Quality Manufacturing126092572024-10-28
TQ26126092581Top Quality Manufacturing126092582024-10-28
TQ26126092621Top Quality Manufacturing126092622024-10-28
TQ26126092641Top Quality Manufacturing126092642024-10-28
TQ26126092661Top Quality Manufacturing126092662024-10-28
TQ26126092681Top Quality Manufacturing126092682024-10-28
TQ26126092691Top Quality Manufacturing126092692024-10-28
TQ26126092701Top Quality Manufacturing126092702024-10-28
TQ26126092721Top Quality Manufacturing126092722024-10-28
TQ26126092731Top Quality Manufacturing126092732024-10-28
TQ26126092791Top Quality Manufacturing126092792024-10-28
TQ26126092831Top Quality Manufacturing126092832024-10-28

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