FDA.reportPublic FDA data

Better Touch

Primary DI
00810007941325
Brand
Better Touch
Company
CENTRAL ASSOCIATION FOR THE BLIND, INC.
Model
880.1
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
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007941325PrimaryGS10
00810007942995Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007941325008100079413258100079413250810007941325
00810007942995008100079429958100079429950810007942995

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
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
00815947004291Better Touch 807.22023-03-29
00815947004307Better Touch 807.32023-03-29
00815947004314Better Touch 807.42023-03-29
00815947004321Better Touch 807.52023-03-29
00815947004338Better Touch 804.22023-03-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14