FDA.reportPublic FDA data

Ultragard

Primary DI
00816928020958
Brand
Ultragard
Company
Ultragard
Model
UGNT8PF-XXL
Device description
box of 50 blue powder free nitrile examination gloves, non-sterile, size XXLarge
Published
2023-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816928025953PackageGS110In Commercial Distribution
00816928020958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928025953008169280259538169280259530816928025953
00816928020958008169280209588169280209580816928020958

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.

Regulatory Flags#

DUNS number
175840941
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816928021313UltragardV300-S2025-02-03
00816928021320UltragardV300-M2025-02-03
00816928021337UltragardV300-L2025-02-03
00816928021344UltragardV300-XL2025-02-03
00816928022716UltragardB300-S2025-02-03
00816928022723UltragardB300-M2025-02-03
00816928022730UltragardB300-L2025-02-03
00816928022747UltragardB300-XL2025-02-03
00816928026318UltragardV300-S2025-02-03
00816928026325UltragardV300-M2025-02-03
00816928026332UltragardV300-L2025-02-03
00816928026349UltragardV300-XL2025-02-03
00816928027711UltragardB300-S2025-02-03
00816928027728UltragardB300-M2025-02-03
00816928027735UltragardB300-L2025-02-03
00816928027742UltragardB300-XL2025-02-03
00816928022501UltragardN300-XS2024-03-19
00816928022556UltragardN300-XXL2024-03-19
00816928027506UltragardN300-XS2024-03-19
00816928027551UltragardN300-XXL2024-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONQDO2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCQDO2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCQDO2026-10-07
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01