FDA.reportPublic FDA data

Uniseal BlackSeal HT

Primary DI
30744514077967
Brand
Uniseal BlackSeal HT
Company
Uniseal
Model
779-6
Device description
Nitrile Powder Free Textured Black 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
Rx
false
OTC
true
Sterile
false
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
30744514077967PackageGS110In Commercial Distribution
20744514077960PrimaryGS10
10744514077963Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3074451407796730744514077967
2074451407796020744514077960
1074451407796310744514077963

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
782209340
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
30744514142283Uniseal Bio-Nit Nitrile422A-82023-10-31
30744514142290Uniseal Bio-Nit Nitrile422A-92023-10-31
30744514015600Uniseal Nitrile Plus X-Tend156-02022-09-05
30744514015662Uniseal Nitrile Plus X-Tend156-62022-09-05
30744514015679Uniseal Nitrile Plus X-Tend156-72022-09-05
30744514015686Uniseal Nitrile Plus X-Tend156-82022-09-05
30744514015693Uniseal Nitrile Plus X-Tend156-92022-09-05
30744514077509Uniseal BlackSeal ST775-02022-08-29
30744514001054Uniseal ProDerma Smooth010-52022-08-22
30744514001061Uniseal ProDerma Smooth010-62022-08-22
30744514001078Uniseal ProDerma Smooth010-72022-08-22

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