FDA.reportPublic FDA data

AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves

Primary DI
00840117352186
Brand
AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves
Company
Dynarex Corporation
Model
6724
Device description
X-Large
Published
2019-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00840117352193PackageGS110In Commercial Distribution
00840117352186PrimaryGS10
00810180847186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117352193008401173521938401173521930840117352193
00840117352186008401173521868401173521860840117352186
00810180847186008101808471868101808471860810180847186

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
008124539
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25
00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,89402018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, Sterile89412018-05-26
00616784894225LabChoice SecureSafety Safety Blood Collection Sets, Sterile89422018-05-26
00616784010014Aluminum Crutches - Child101002019-09-30
00840117346505PA Safety Lancets, Pressure Activated, 21 G Needle71132026-06-01
00840117343788Dynacare HerCare Necessities Complete Kit13752026-05-29
00616784213132Shoe Cover Non-Conductive, Universal21312021-06-21
00616784213231Shoe Cover Non-Conductive, Non-Skid, Universal Size21322021-06-21
00616784213439Shoe Cover Non-Conductive, Non-Skid, X-Large21342021-06-21
00616784426518IV Pole Kit For Enteral Irrigation, Non-Sterile42652021-09-01
00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
00616784562117DynaLift Transport Unit, Black, 40" x 80" (101.6 cm x 203.2 cm)56212021-04-22
00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
00840117309036Resp-O2 Single Suction Catheter, 16 FR320052022-05-10
00840117309050Resp-O2 Single Suction Catheter, 18 FR320062022-05-10
00840117310285Resp-O2 Single Suction Catheter, 6 FR320002022-05-10

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