FDA.reportPublic FDA data

NITRI-COR

Primary DI
00796326035849
Brand
NITRI-COR
Company
International Sourcing Company, Inc.
Model
4087M
Catalog number
4087M
Device description
EXAMINATION GLOVES NITRILE POWDER FREE
Published
2023-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
30796326035840PackageGS11000In Commercial Distribution
00796326035849PrimaryGS10
50796326035844Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3079632603584030796326035840
00796326035849007963260358497963260358490796326035849
5079632603584450796326035844

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature30 Degrees Fahrenheit105 Degrees Fahrenheit
Storage Environment Temperature30 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
9014585030rhonda.camp@cordovaisc.com

Regulatory Flags#

DUNS number
873018162
Device count
100
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00796326000922DURA-COR4030L4030L2023-07-21
00796326035832NITRI-COR4087L4087L2023-07-28
00796326035856NITRI-COR4087S4087S2023-08-01
00796326035863NITRI-COR4087XL4087XL2023-08-01
00796326035870NITRI-COR4087XXL4087XXL2023-08-01
30796326035857NITRI-COR4087S4087S2023-08-01
30796326035864NITRI-COR4087XL4087XL2023-08-01
30796326035871NITRI-COR4087XXL4087XXL2023-08-01
00796326000939DURA-COR4030M4030M2023-07-28
00796326000946DURA-COR4030S4030S2023-07-28
00796326000953DURA-COR4030XL4030XL2023-07-28
30796326000930DURA-COR4030M4030M2023-07-28
30796326000947DURA-COR4030S4030S2023-07-28
30796326000954DURA-COR4030XL4030XL2023-07-28
30796326035833NITRI-COR4087L4087L2023-07-28
30796326035840NITRI-COR4087M4087M2023-07-28
30796326000923DURA-COR4030L4030L2023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15