FDA.reportPublic FDA data

Shield Gloves

Primary DI
00840369300102
Brand
Shield Gloves
Company
B D G Wrap-Tite, Inc.
Model
GLVNMPFB-XL
Device description
Black Nibrid Glove, Exam Grade, Powder Free, Smooth Textured, Extra Large, Inner Pack
Published
2024-11-19
Public version status
Update
Distribution status
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840369300102PrimaryGS10
00840369300096Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840369300102008403693001028403693001020840369300102
00840369300096008403693000968403693000960840369300096

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
No natural rubber latex
true

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
00840369321602Shield GlovesGLNMPFL3-S2024-11-13
00840369321633Shield GlovesGLNMPFL3-M2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
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00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
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