FDA.report

Ultragard

Primary DI
00816928025236
Brand
Ultragard
Company
Ultragard
Model
UGET-L
Device description
box of 50 blue powder free latex examination gloves, non-sterile, size Large
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

Related Records

Product Codes

CodeName
LZCMedical Glove, Specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816928025236PackageGS110In Commercial Distribution
00816928020231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928025236008169280252368169280252360816928025236
00816928020231008169280202318169280202310816928020231

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
00816928027506UltragardN300-XS2024-03-19
00816928027551UltragardN300-XXL2024-03-19
00816928025250UltragardUGET-XXL2023-10-10
00816928025601UltragardUGNTPF-XS2023-05-25
00816928025618UltragardUGNTPF-S2023-05-25
00816928025625UltragardUGNTPF-M2023-05-25
00816928025632UltragardUGNTPF-L2023-05-25
00816928025649UltragardUGNTPF-XL2023-05-25
00816928028008UltragardL300-XS2023-05-25
00816928028015UltragardL300-S2023-05-25
00816928028022UltragardL300-M2023-05-25
00816928028039UltragardL300-L2023-05-25

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