FDA.reportPublic FDA data

Ultraguard

Primary DI
00860010844861
Brand
Ultraguard
Company
True Products International, LLC
Model
TPI300
Device description
Nitrile Powder Free Examination Glove (L) (300 pcs / inner box)
Published
2024-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10860010844868PackageGS110In Commercial Distribution
00860010844861PrimaryGS10
00860010844847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001084486810860010844868
00860010844861008600108448618600108448610860010844861
00860010844847008600108448478600108448470860010844847

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
117481821
Device count
300
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010844816UltraguardTPI1002024-05-09
00860010844830UltraguardTPI1002024-05-09
00860010844854UltraguardTPI1002024-05-09
00860010844878UltraguardTPI1002024-05-09
00860010844892UltraguardTPI1002024-05-09
10860010844813UltraguardTPI1002024-05-09
10860010844837UltraguardTPI1002024-05-09
10860010844851UltraguardTPI1002024-05-09
10860010844875UltraguardTPI1002024-05-09
10860010844899UltraguardTPI1002024-05-09
00860010844885UltraguardTPI3002024-04-29
10860010844868UltraguardTPI3002024-04-29
10860010844882UltraguardTPI3002024-04-29
00860010844809UltraguardTPI3002024-04-24
10860010844806UltraguardTPI3002024-04-24
00860010844823UltraguardTPI3002024-04-19
10860010844820UltraguardTPI3002024-04-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10813172025477NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025484NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025491NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025507NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025514NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025422NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
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
10076490788688MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788695MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10860011343872BIONEXMedzah IndustriesOPJ2025-07-30
10860011343889BIONEXMedzah IndustriesOPJ2025-07-30
10860011343896BIONEXMedzah IndustriesOPJ2025-07-30
10860011725401BIONEXMedzah IndustriesOPJ2025-07-30