FDA.reportPublic FDA data

AmerCareRoyal Ultra-Flex Powder-Free Latex Exam Gloves

Primary DI
00811033010337
Brand
AmerCareRoyal Ultra-Flex Powder-Free Latex Exam Gloves
Company
Amercareroyal, LLC
Model
3002
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
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
00811033010337PackageGS110In Commercial Distribution
00811033010191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811033010337008110330103378110330103370811033010337
00811033010191008110330101918110330101910811033010191

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
true
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

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