FDA.reportPublic FDA data

Sempermed iconiX bi-fusion

Primary DI
00841277110296
Brand
Sempermed iconiX bi-fusion
Company
SEMPERMED USA, INC.
Model
ICNX 103
Catalog number
ICNX 103
Device description
Sempermed iconiX bi-fusion Nitrile Examination Gloves (M)
Published
2025-04-28
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00841277110241PrimaryGS10
00841277110296Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841277110241008412771102418412771102410841277110241
00841277110296008412771102968412771102960841277110296

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004072158
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841277110739Caracal Velvet XP24477244772025-08-12
00841277110746Caracal Velvet XP24478244782025-08-12
00841277110753Caracal Velvet XP24479244792025-08-12
00841277110760Caracal Velvet XP24480244802025-08-12
00841277110777Caracal Velvet XP24481244812025-08-12
00841277110289Sempermed iconiX bi-fusionICNX 102ICNX 1022025-04-28
00841277110302Sempermed iconiX bi-fusionICNX 104ICNX 1042025-04-28
00841277110319Sempermed iconiX bi-fusionICNX 105ICNX 1052025-04-28
00841277110326Sempermed iconiX bi-fusionICNX 106ICNX 1062025-04-28
00841277110395Sempermed iconiX bi-fusionSPK-ICNXSPK-ICNX2025-04-28
00841277110456Sempermed vinyl comfortEVNP101EVNP1012025-04-28
00841277110463Sempermed vinyl comfortEVNP102EVNP1022025-04-28
00841277110470Sempermed vinyl comfort Exam GloveEVNP103EVNP1032025-04-28
00841277110487Sempermed vinyl comfort EVNP104EVNP1042025-04-28
00841277110494Sempermed vinyl comfort Exam GloveEVNP105EVNP1052025-04-28
00841277110555Sempermed syn-stretch Vinyl Exam GloveSCVNP101SCVNP1012025-04-28
00841277110562Semperguard sun-stretch Vinyl Exam GloveSCVNP102SCVNP1022025-04-28
00841277110579Sempermed vinyl syn-stretch Exam GloveSCVNP103SCVNP1032025-04-28
00841277110586Sempermed vinyl syn-stretch Exam GloveSCVNP104SCVNP1042025-04-28
00841277110593Sempermed vinyl syn-stretch Exam GloveSCVNP105SCVNP1052025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536900219BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.OPJ2026-09-18
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