FDA.reportPublic FDA data

VetOne

Primary DI
60313985100583
Brand
VetOne
Company
KVP International, Inc.
Model
610283
Device description
VetOne biodegradable nitrile exam glove, X-Large, 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

Product Codes#

Code, Name table
CodeName
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60313985100583PackageGS110In Commercial Distribution
00313985100581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6031398510058360313985100583
00313985100581003139851005813139851005810313985100581

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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742061700238KVPLG-S2025-08-12
00742061700245KVPLG-M2025-08-12
00742061700269KVPLG-XL2025-08-12
20742061700232KVPLG-S2025-08-12
20742061700249KVPLG-M2025-08-12
00742061700252KVPLG-L2025-08-12
20742061700263KVPLG-XL2025-08-12
00742061700177KVPBWM-42025-07-01
00742061700184KVPBWN-22025-07-01
00313985100550VetOne6102802024-08-01
00313985100567VetOne6102812024-08-01
00313985100574VetOne6102822024-08-01
00313985100581VetOne6102832024-08-01
60313985100552VetOne6102802024-08-01
60313985100569VetOne6102812024-08-01
60313985100576VetOne6102822024-08-01
00742061050517mVetMVBGM2023-01-31
00742061050524mVetMVBGL2023-01-31
00742061050531mVetMVBGXL2023-01-31
00742061060318KVPBG-S2023-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169610312NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCOPJ2026-07-06
20680651502388HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502395HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502401HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502418HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651502425HalyardO&M HALYARD, INC.OPJ2026-06-04
20680651489535HalyardO&M HALYARD, INC.OPJ2026-03-12
10857420007600EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007617EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007624EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007631EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10857420007648EnSureECON DISPOSABLE SUPPLIES, INCOPJ2026-01-09
10813172025477NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025484NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025491NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025507NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025514NitriDerm® BiodegradableINNOVATIVE HEALTHCARE CORPORATIONOPJ2025-12-22
10813172025422NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025439NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025446NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025453NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10813172025460NitriDerm® 100INNOVATIVE HEALTHCARE CORPORATIONOPJ2025-11-12
10076490788657MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788664MICROFLEX Ansell Healthcare ProductOPJ2025-08-05
10076490788671MICROFLEXAnsell Healthcare ProductOPJ2025-08-05
10076490788688MICROFLEXAnsell Healthcare ProductOPJ2025-08-05