FDA.reportPublic FDA data

CareOne

Primary DI
00041520125019
Brand
CareOne
Company
Ahold U.S.A., Inc.
Model
041520125019
Device description
Powder Free Nitrile Gloves, 50 single use only gloves (by weight), one size
Published
2019-11-29
Public version status
Update
Distribution status
Not 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
10041520125016PackageGS124Not in Commercial Distribution
00041520125019PrimaryGS10
60041520125011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152012501610041520125016
00041520125019000415201250190415201250190041520125019
6004152012501160041520125011

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing. Avoid excessive heat. Keep dry.

Regulatory Flags#

DUNS number
170199058
Device count
50
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041520078438CareOne0415200784382019-08-30
00041520010704CareOne0415200107042019-06-28
00041520013965CareOne0415200139652020-09-27
00041520014009CareOne0415200140092019-06-28
00041520019714CareOne0415200197142019-06-28
00041520089298CareOne0415200892982019-07-31
00041520089304CareOne0415200893042019-06-28
00041520096777CareOne0415200967772019-07-31
00041520096784CareOne0415200967842019-07-31
00041520096791CareOne0415200967912019-06-28
00041520096821CareOne0415200968212019-06-28
00041520125033CareOne0415201250332019-07-31
00041520875754CareOne0415208757542019-06-28
00041520877710CareOne0415208777102019-06-28
00041520877727CareOne0415208777272019-06-28
00041520880963CareOne0415208809632019-06-28
00341520317170CareOne3415203171702020-09-27
00341520877889CareOne3415208778892019-07-31
00041520171283Care OneDigital Pregnancy Test2021-04-22
00041520171269Care OneOne Step Pregnancy Test2021-04-22

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00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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