FDA.reportPublic FDA data

Ultragard

Primary DI
00816928025946
Brand
Ultragard
Company
Ultragard
Model
UGNT8PF-XL
Device description
box of 50 blue powder free nitrile examination gloves, non-sterile, size XLarge
Published
2023-01-17
Public version status
Update
Distribution status
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816928025946PackageGS110In Commercial Distribution
00816928020941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928025946008169280259468169280259460816928025946
00816928020941008169280209418169280209410816928020941

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
175840941
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZC2026-10-07
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14