FDA.reportPublic FDA data

KVP

Primary DI
00742061060318
Brand
KVP
Company
KVP International, Inc.
Model
BG-S
Device description
Biodegradable nitrile gloves, 100 pack, size Small
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00742061060448PackageGS110In Commercial Distribution
00742061060318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742061060448007420610604487420610604480742061060448
00742061060318007420610603187420610603180742061060318

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.

Regulatory Flags#

DUNS number
137826512
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
60313985100583VetOne6102832024-08-01
00742061050517mVetMVBGM2023-01-31
00742061050524mVetMVBGL2023-01-31
00742061050531mVetMVBGXL2023-01-31

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
00810145952115NeuleafMedgluv Inc.OPJ2026-06-30
00810145952122NeuleafMedgluv Inc.OPJ2026-06-30
00810145952139NeuleafMedgluv Inc.OPJ2026-06-30
00810145952146NeuleafMedgluv Inc.OPJ2026-06-30
00810145952108NeuleafMedgluv Inc.OPJ2026-06-29
00850005229568NeuflexMedgluv Inc.OPJ2026-06-29
00850005229575NeuflexMedgluv Inc.OPJ2026-06-29
00850005229582NeuflexMedgluv Inc.OPJ2026-06-29
00850005229599NeuflexMedgluv Inc.OPJ2026-06-29
00850005229605NeuflexMedgluv Inc.OPJ2026-06-29
00850005229612NeuflexMedgluv Inc.OPJ2026-06-29
00810145951972NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951989NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145951996NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952009NeuPro 16Medgluv Inc.OPJ2026-06-26
00810145952153NeulynxMedgluv Inc.OPJ2026-06-26
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