FDA.reportPublic FDA data

AmerCareRoyal Grape Grip Powder-Free Nitrile Exam Gloves

Primary DI
00811033010634
Brand
AmerCareRoyal Grape Grip Powder-Free Nitrile Exam Gloves
Company
Amercareroyal, LLC
Model
6003
Published
2022-12-01
Public version status
New
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
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811033010634PackageGS110In Commercial Distribution
00811033010627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811033010634008110330106348110330106340811033010634
00811033010627008110330106278110330106270811033010627

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
002326965
Device count
1
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
true
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
00072288164415Merit Blue Ntrile Examination Gloes Powder FreeME-5025-L2023-10-25
00072288164422Merit Blue Ntrile Examination Gloes Powder FreeME-5025-M2023-10-25
00072288164439Merit Blue Ntrile Examination Gloes Powder FreeME-5025-S2023-10-25
00072288164453Merit Black Ntrile Examination Gloes Powder FreeME-5050-L2023-10-25
00072288164460Merit Black Ntrile Examination Gloes Powder FreeME-5050-M2023-10-25
00072288164477Merit Black Ntrile Examination Gloes Powder FreeME-5050-S2023-10-25
00072288164484Merit Black Ntrile Examination Gloes Powder FreeME-5050-XL2023-10-25
00072288164279Merit Blue Ntrile Examination Gloes Powder FreeME-5025-L2023-10-25
00072288164286Merit Blue Ntrile Examination Gloes Powder FreeME-5025-M2023-10-25
00072288164293Merit Blue Ntrile Examination Gloes Powder FreeME-5025-S2023-10-25
00072288164446Merit Blue Ntrile Examination Gloes Powder FreeME-5025-XL2023-10-25
00072288164316Merit Black Ntrile Examination Gloes Powder FreeME-5050-L2023-10-25
00072288164323Merit Black Ntrile Examination Gloes Powder FreeME-5050-M2023-10-25
00072288164330Merit Black Ntrile Examination Gloes Powder FreeME-5050-S2023-10-25
00072288164347Merit Black Ntrile Examination Gloes Powder FreeME-5050-XL2023-10-25
00072288164521AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432022023-10-08
00072288164545AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432032023-10-08
00072288164569AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432042023-10-08
00072288164583AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432052023-10-08
00072288164507AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432012023-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10