FDA.reportPublic FDA data

Shield Gloves

Primary DI
00840369313201
Brand
Shield Gloves
Company
B D G Wrap-Tite, Inc.
Model
GLNMPFL6-L
Device description
Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, 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
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840369313201PrimaryGS10
00840369313195Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840369313201008403693132018403693132010840369313201
00840369313195008403693131958403693131950840369313195

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
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
00840369321633Shield GlovesGLNMPFL3-M2024-11-15

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Primary DI, Brand, Company table
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