FDA.reportPublic FDA data

Vital Edge Instruments LLC

Primary DI
00860014221309
Brand
Vital Edge Instruments LLC
Company
Vital Edge Instruments LLC
Model
M4_BLU_NIT_MED_GLOVE_M
Device description
M4.0+_0.3g Blue Nitrile Gloves Medical Grade, M Size1 box contains 100 gloves
Published
2025-10-11
Public version status
Update
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014221309PrimaryGS10
00199284076150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014221309008600142213098600142213090860014221309
00199284076150001992840761501992840761500199284076150

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store in a cool and dry place. Avoid direct sunlight.

Regulatory Flags#

DUNS number
129069965
Device count
100
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014221316Vital Edge Instruments LLCL4_BLU_NIT_MED_GLOVE_M2025-10-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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