FDA.reportPublic FDA data

Ultragard

Primary DI
00816928021344
Brand
Ultragard
Company
Ultragard
Model
V300-XL
Device description
box of 100 powder free vinyl examination gloves, non-sterile, size XLarge
Published
2025-02-03
Public version status
New
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
LYZVinyl Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816928026349PackageGS110In Commercial Distribution
00816928021344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928026349008169280263498169280263490816928026349
00816928021344008169280213448169280213440816928021344

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
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
00816928020255UltragardUGET-XXL2023-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916625Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916632Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916649Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916656Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10810141931265VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931272VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931289VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931296VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931302VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10097604870006Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870013Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870020Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870037Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870044Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10755676000843ADI MedicalADI MedicalLYZ2023-11-27
10755676000850ADI MedicalADI MedicalLYZ2023-11-27
10755676000867ADI MedicalADI MedicalLYZ2023-11-27
10755676001482ADI MedicalADI MedicalLYZ2023-11-27
10755676001499ADI MedicalADI MedicalLYZ2023-11-27
10755676001512ADI MedicalADI MedicalLYZ2023-11-27
10813172024609DermAssist®INNOVATIVE HEALTHCARE CORPORATIONLYZ2023-09-01