FDA.reportPublic FDA data

DOMREX™ PI GLOVES

Primary DI
00628032222803
Brand
DOMREX™ PI GLOVES
Company
Domrex Pharma Inc
Model
80
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
10628032222800PackageGS14In Commercial Distribution
00628032222803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062803222280010628032222800
00628032222803006280322228036280322228030628032222803

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
00628032222858DOMREX™ PI GLOVES852024-01-19
00628032222902DOMREX™ PI GLOVES902024-01-19
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
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20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502425HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651489535HalyardO&M HALYARD, INC.OPJ2026-03-12
10857420007600EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007617EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007624EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007631EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007648EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
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10813172025491NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025507NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
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10813172025439NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025446NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025453NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025460NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10076490788657MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductOPJ2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
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10076490788695MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
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