FDA.reportPublic FDA data

HandPlus Nitrile XT8

Primary DI
20744514008865
Brand
HandPlus Nitrile XT8
Company
Uniseal
Model
088-6
Device description
Nitrile Powder Free Diamond Textured Orange Exam Gloves, Non- Sterile, size S
Published
2022-08-22
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
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
30744514008862PackageGS110In Commercial Distribution
20744514008865PrimaryGS10
10744514008868Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3074451400886230744514008862
2074451400886520744514008865
1074451400886810744514008868

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.

Regulatory Flags#

DUNS number
782209340
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20744514101504Uniseal High Risk Nitrile015X-02023-10-31
20744514101566Uniseal High Risk Nitrile015X-62023-10-31
20744514101573Uniseal High Risk Nitrile015X-72023-10-31
20744514101580Uniseal High Risk Nitrile015X-82023-10-31
20744514101597Uniseal High Risk Nitrile015X-92023-10-31
20744514142200Uniseal Bio-Nit Nitrile422A-02023-10-31
20744514142255Uniseal Bio-Nit Nitrile422A-52023-10-31
20744514142262Uniseal Bio-Nit Nitrile422A-62023-10-31
20744514142279Uniseal Bio-Nit Nitrile422A-72023-10-31
20744514142286Uniseal Bio-Nit Nitrile422A-82023-10-31
20744514142293Uniseal Bio-Nit Nitrile422A-92023-10-31
30744514101501Uniseal High Risk Nitrile015X-02023-10-31
30744514101563Uniseal High Risk Nitrile015X-62023-10-31
30744514101570Uniseal High Risk Nitrile015X-72023-10-31
30744514101587Uniseal High Risk Nitrile015X-82023-10-31
30744514101594Uniseal High Risk Nitrile015X-92023-10-31
30744514142207Uniseal Bio-Nit Nitrile422A-02023-10-31
30744514142252Uniseal Bio-Nit Nitrile422A-52023-10-31
30744514142269Uniseal Bio-Nit Nitrile422A-62023-10-31
30744514142276Uniseal Bio-Nit Nitrile422A-72023-10-31

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Primary DI, Brand, Company table
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