FDA.reportPublic FDA data

AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves

Primary DI
00072288164583
Brand
AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves
Company
Amercareroyal, LLC
Model
43205
Published
2023-10-08
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
LZCMedical 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
00072288164576PackageGS110In Commercial Distribution
00072288164583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00072288164576000722881645760722881645760072288164576
00072288164583000722881645830722881645830072288164583

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
002326965
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00072288164507AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432012023-10-08
00072288164514AmerCareRoyal Nitra-Med Powder-Free Nitrile Exam Gloves432022023-10-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04