FDA.reportPublic FDA data

Stronghold Group Nitrile Examination Glove, Powder Free-M

Primary DI
00860007372216
Brand
Stronghold Group Nitrile Examination Glove, Powder Free-M
Company
The Stronghold Group LLC
Model
SHFBSNS0603M
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: M Pack: 100 pieces by weight / inner box.
Published
2022-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00860007372254PackageGS110In Commercial Distribution
00860007372216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007372254008600073722548600073722540860007372254
00860007372216008600073722168600073722160860007372216

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
080344373
Device count
1
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
00850037694648Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694655Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694662Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694679Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694686Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694730Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694747Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694754Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694761Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694778Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19
10850037694645Stronghold PP/PE Isolation Gown (AAMI Level 2)-SSC200S2022-03-19
00850037694693Stronghold PP/PE Isolation Gown (AAMI Level 2)-MSC200M2022-03-19
00850037694709Stronghold PP/PE Isolation Gown (AAMI Level 2)-LSC200L2022-03-19
00850037694716Stronghold PP/PE Isolation Gown (AAMI Level 2)-XLSC200XL2022-03-19
00850037694723Stronghold PP/PE Isolation Gown (AAMI Level 2)-UnisizeSC200U2022-03-19
00850037694785Stronghold SMS Isolation Gown (AAMI Level 2)-SSC210S2022-03-19
00850037694792Stronghold SMS Isolation Gown (AAMI Level 2)-MSC210M2022-03-19
00850037694808Stronghold SMS Isolation Gown (AAMI Level 2)-LSC210L2022-03-19
00850037694815Stronghold SMS Isolation Gown (AAMI Level 2)-XLSC210XL2022-03-19
00850037694822Stronghold SMS Isolation Gown (AAMI Level 2)-UnisizeSC210U2022-03-19

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