FDA.reportPublic FDA data

Better Touch

Primary DI
00815947004338
Brand
Better Touch
Company
CENTRAL ASSOCIATION FOR THE BLIND, INC.
Model
804.2
Published
2023-03-29
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
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815947004338PrimaryGS10
00810007942681Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815947004338008159470043388159470043380815947004338
00810007942681008100079426818100079426810810007942681

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
099903148
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007941271Better Touch 880.22023-03-29
00810007941288Better Touch 880.32023-03-29
00810007941295Better Touch 880.42023-03-29
00810007941301Better Touch 880.52023-03-29
00810007941318Better Touch 880.62023-03-29
00810007941325Better Touch 880.12023-03-29
00815947004291Better Touch 807.22023-03-29
00815947004307Better Touch 807.32023-03-29
00815947004314Better Touch 807.42023-03-29
00815947004321Better Touch 807.52023-03-29
00815947004345Better Touch 804.32023-03-29
00815947004352Better Touch 804.42023-03-29
00815947004369Better Touch 804.52023-03-29
00815947004376Better Touch 802.52023-03-29
00815947004383Better Touch 802.22023-03-29
00815947004390Better Touch 802.32023-03-29
00815947004406Better Touch 802.42023-03-29
00815947004451Better Touch825.22023-03-29
00815947004468Better Touch 825.32023-03-29
00815947004475Better Touch 825.42023-03-29

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