FDA.reportPublic FDA data

NITRI-COR

Primary DI
30796326035833
Brand
NITRI-COR
Company
International Sourcing Company, Inc.
Model
4087L
Catalog number
4087L
Device description
EXAMINATION GLOVES LATEX POWDER FREE
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
30796326035833PackageGS11000In Commercial Distribution
00796326035832PrimaryGS10
50796326035837Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3079632603583330796326035833
00796326035832007963260358327963260358320796326035832
5079632603583750796326035837

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
873018162
Device count
1000
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00796326000922DURA-COR4030L4030L2023-07-21
00796326035832NITRI-COR4087L4087L2023-07-28
00796326035849NITRI-COR4087M4087M2023-07-28
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
30796326035840NITRI-COR4087M4087M2023-07-28
30796326000923DURA-COR4030L4030L2023-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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