FDA.reportPublic FDA data

DOMREX™ PI GLOVES

Primary DI
00628032222902
Brand
DOMREX™ PI GLOVES
Company
Domrex Pharma Inc
Model
90
Published
2024-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628032222909PackageGS14In Commercial Distribution
00628032222902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062803222290910628032222909
00628032222902006280322229026280322229020628032222902

GMDN Terms#

Term, Definition table
TermDefinition
Polyisoprene surgical glove, non-powdered, non-antimicrobialA device made of polyisoprene intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
242411127
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628032900015DOMREX™ Powder-Free Nitrile Exam GlovesXS2024-01-22
00628032000012DOMREX™ Syringe1ml LDS2024-01-19
00628032000036DOMREX™ Syringe3ML2024-01-19
00628032000050DOMREX™ Syringe5ML2024-01-21
00628032000104DOMREX™ Syringe10ML2024-01-21
00628032025107DOMREX™ Safety needle25Gx1''2024-01-21
00628032125104DOMREX™ Syringe with safety needle1ML2024-01-21
00628032222551DOMREX™ PI GLOVES552024-01-19
00628032222605DOMREX™ PI GLOVES602024-01-19
00628032222650DOMREX™ PI GLOVES652024-01-19
00628032222704DOMREX™ PI GLOVES702024-01-19
00628032222759DOMREX™ PI GLOVES752024-01-19
00628032222803DOMREX™ PI GLOVES802024-01-19
00628032222858DOMREX™ PI GLOVES852024-01-19
00628032325108DOMREX™ Syringe with safety needle3ML2024-01-21
00628032333370DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' 2024-01-19
00628032333387DOMREX™ Safety Blood Collection Set23G x 3/4” 12'' 2024-01-19
00628032333431DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' Holder2024-01-19
00628032333448DOMREX™ Safety Blood Collection Set23G x 3/4” 12'' Holder2024-01-19
00628032333530DOMREX™ Safety Blood Collection Set21G x 3/4” 12'' Luer Adapter2024-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.OPJ2026-07-17
00850005229810NeulynxMedgluv Inc.OPJ2026-07-17
00850005229827NeulynxMedgluv Inc.OPJ2026-07-17
00850005229834NeulynxMedgluv Inc.OPJ2026-07-17
00850005229841NeulynxMedgluv Inc.OPJ2026-07-17
00810169610312NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810145952115NeuleafMedgluv Inc.OPJ2026-06-30
00810145952122NeuleafMedgluv Inc.OPJ2026-06-30
00810145952139NeuleafMedgluv Inc.OPJ2026-06-30
00810145952146NeuleafMedgluv Inc.OPJ2026-06-30
00810145952108NeuleafMedgluv Inc.OPJ2026-06-29
00850005229568NeuflexMedgluv Inc.OPJ2026-06-29
00850005229575NeuflexMedgluv Inc.OPJ2026-06-29
00850005229582NeuflexMedgluv Inc.OPJ2026-06-29
00850005229599NeuflexMedgluv Inc.OPJ2026-06-29
00850005229605NeuflexMedgluv Inc.OPJ2026-06-29
00850005229612NeuflexMedgluv Inc.OPJ2026-06-29
00810145951972NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951989NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951996NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952009NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952153NeulynxMedgluv Inc.OPJ2026-06-26
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04