FDA.reportPublic FDA data

Inspire

Primary DI
00816554015144
Brand
Inspire
Company
K2 Health Products LLC
Model
INSLBNG-L
Device description
Inspire Light Blue Exam Grade Nitrile Gloves Size Large
Published
2024-06-21
Public version status
New
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
10816554015141PackageGS110In Commercial Distribution
00816554015144PrimaryGS10
50816554015149Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081655401514110816554015141
00816554015144008165540151448165540151440816554015144
5081655401514950816554015149

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(718)451-4444info@k2health.com

Regulatory Flags#

DUNS number
800616612
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816554015403InspireINSVPBBLUG-S2024-09-17
00816554015410InspireINSVPBBLUG-M2024-09-17
00816554015427InspireINSVPBBLUG-L2024-09-17
00816554015434InspireINSVPBBLUG-XL2024-09-17
10816554015400InspireINSVPBBLUG-S2024-09-17
10816554015417InspireINSVPBBLUG-M2024-09-17
10816554015424InspireINSVPBBLUG-L2024-09-17
10816554015431InspireINSVPBBLUG-XL2024-09-17
00816554015441InspireINSTFNG-S2024-09-11
00816554015458InspireINSTFNG-M2024-09-11
00816554015465InspireINSTFNG-L2024-09-11
00816554015472InspireINSTFNG-XL2024-09-11
10816554015448InspireINSTFNG-S2024-09-11
10816554015455InspireINSTFNG-M2024-09-11
10816554015462InspireINSTFNG-L2024-09-11
10816554015479InspireINSTFNG-XL2024-09-11
00816554015120InspireINSLBNG-S2024-06-21
00816554015137InspireINSLBNG-M2024-06-21
00816554015151InspireINSLBNG-XL2024-06-21
00816554015168InspireINSLBNG-XXL2024-06-21

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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