FDA.reportPublic FDA data

Ultragard

Primary DI
00816928025250
Brand
Ultragard
Company
Ultragard
Model
UGET-XXL
Device description
box of 50 blue powder free latex examination gloves, non-sterile, size XXLarge
Published
2023-10-10
Public version status
New
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
00816928025250PackageGS110In Commercial Distribution
00816928020255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928025250008169280252508169280252500816928025250
00816928020255008169280202558169280202550816928020255

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
true
No natural rubber latex
false
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
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09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12