FDA.reportPublic FDA data

Shield Gloves

Primary DI
00085004857461
Brand
Shield Gloves
Company
B D G Wrap-Tite, Inc.
Model
GLNMPFO8D-S
Device description
Nitrile Gloves, Exam Grade, Powder Free, Orange, Full Diamond Textured, Small, Inner Pack
Published
2023-03-07
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
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
00085004857461PrimaryGS10
00850048574601Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085004857461000850048574610850048574610085004857461
00850048574601008500485746018500485746010850048574601

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
076901110
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840369313140Shield GlovesGLNMPFL6-S2024-11-18
00840369313171Shield GlovesGLNMPFL6-M2024-11-19
00840369313201Shield GlovesGLNMPFL6-L2024-11-19
00840369313232Shield GlovesGLNMPFL6-XL2024-11-19
00840369315359Shield GlovesGLNMPFB6-S2024-11-15
00840369321848Shield GlovesGLNMPFL6-2XL2024-11-19
00850046161582Shield GlovesGLNMPFL-2XL2023-02-22
00850046161612Shield GlovesGLNMPFL-XL2022-11-25
00850046161650Shield GlovesGLNMPFL-L2022-11-25
00850046161681Shield GlovesGLNMPFL-M2022-11-25
00850046161711Shield GlovesGLNMPFL-S2022-11-25
00850046161865Shield GlovesGLNMPFB6-M2022-12-06
00850046161896Shield GlovesGLNMPFB6-L2022-12-06
00850046161926Shield GlovesGLNMPFB6-XL2022-12-06
00850046161957Shield GlovesGLNMPFB6-2XL2022-12-06
00840369300010Shield GlovesGLVNMPFB-S2024-11-19
00840369300041Shield GlovesGLVNMPFB-M2024-11-19
00840369300072Shield GlovesGLVNMPFB-L2024-11-19
00840369300102Shield GlovesGLVNMPFB-XL2024-11-19
00840369321602Shield GlovesGLNMPFL3-S2024-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
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
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952429NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952436NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952443NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952450NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952467NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29