FDA.report

VetOne

Primary DI
60313985100552
Brand
VetOne
Company
KVP International, Inc.
Model
610280
Device description
VetOne biodegradable nitrile exam glove, Small, 100ct
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications

CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60313985100552PackageGS110In Commercial Distribution
00313985100550PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
137826512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20742061700232KVPLG-S2025-08-12
20742061700249KVPLG-M2025-08-12
00742061700252KVPLG-L2025-08-12
20742061700263KVPLG-XL2025-08-12
00742061700177KVPBWM-42025-07-01
00742061700184KVPBWN-22025-07-01
60313985100569VetOne6102812024-08-01
60313985100576VetOne6102822024-08-01
60313985100583VetOne6102832024-08-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
90680651496938HalyardO&M HALYARD, INC.OPJ2025-05-17
90680651496945HalyardO&M HALYARD, INC.OPJ2025-05-17
90680651496952HalyardO&M HALYARD, INC.OPJ2025-05-17
90680651496969HalyardO&M HALYARD, INC.OPJ2025-05-17
90680651496976HalyardO&M HALYARD, INC.OPJ2025-05-17
90680651496983HalyardO&M HALYARD, INC.OPJ2025-05-17
00841277110296Sempermed iconiX bi-fusionSEMPERMED USA, INC.OPJ2025-04-28
00841277110302Sempermed iconiX bi-fusionSEMPERMED USA, INC.OPJ2025-04-28
00841277110319Sempermed iconiX bi-fusionSEMPERMED USA, INC.OPJ2025-04-28
00841277110326Sempermed iconiX bi-fusionSEMPERMED USA, INC.OPJ2025-04-28
00841277110395Sempermed iconiX bi-fusionSEMPERMED USA, INC.OPJ2025-04-28
00841277110135Sempermed skySenseSEMPERMED USA, INC.OPJ2025-03-17
00841277110142Sempermed skySenseSEMPERMED USA, INC.OPJ2025-03-17
00841277110159Sempermed skySenseSEMPERMED USA, INC.OPJ2025-03-17
00841277110166Sempermed skySenseSEMPERMED USA, INC.OPJ2025-03-17
00841277110173Sempermed skySenseSEMPERMED USA, INC.OPJ2025-03-17
00841277109344safeSEMPERMED USA, INC.OPJ2025-01-24
00841277109894force+SEMPERMED USA, INC.OPJ2025-01-24
00841277109900force+SEMPERMED USA, INC.OPJ2025-01-24
00841277109917force+SEMPERMED USA, INC.OPJ2025-01-24
00841277109924force+SEMPERMED USA, INC.OPJ2025-01-24
00841277109931force+SEMPERMED USA, INC.OPJ2025-01-24
00841277109948force+SEMPERMED USA, INC.OPJ2025-01-24
00810143620115GenaCheck® Nitrile Powder Free Examination GloveGenabio Diagnostics Inc.OPJ2025-01-13
00810143620139GenaCheck® Nitrile Powder Free Examination GloveGenabio Diagnostics Inc.OPJ2025-01-13
00810143620146GenaCheck® Nitrile Powder Free Examination GloveGenabio Diagnostics Inc.OPJ2025-01-13
00810143620153GenaCheck® Nitrile Powder Free Examination GloveGenabio Diagnostics Inc.OPJ2025-01-13
00841277108897velvet XP 200SEMPERMED USA, INC.OPJ2024-11-15
00841277108910velvet XP 200SEMPERMED USA, INC.OPJ2024-11-15
00841277108927velvet XP 200SEMPERMED USA, INC.OPJ2024-11-15