FDA.report

Ultragard

Primary DI
00816928027520
Brand
Ultragard
Company
Ultragard
Model
N300-M
Device description
box of 100 blue powder free nitrile examination gloves, non-sterile, size Medium
Published
2023-03-21
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

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816928027520PackageGS110In Commercial Distribution
00816928022525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816928027520008169280275208169280275200816928027520
00816928022525008169280225258169280225250816928022525

GMDN Terms

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

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 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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