FDA.reportPublic FDA data

MEDLINE

Primary DI
40080196994893
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
484401
Catalog number
484401
Device description
GLOVE,EXAM,VINYL,STERILE,PF,LF,SGL,SM
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196994893PackageGS14In Commercial Distribution
30080196994896PrimaryGS10
10080196994892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019699489340080196994893
3008019699489630080196994896
1008019699489210080196994892

GMDN Terms#

Term, Definition table
TermDefinition
Ethylene vinyl acetate examination/treatment glove, non-powderedA device made of ethylene vinyl acetate (EVA) copolymer 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/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
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081586MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
20193489081593MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
10889483584446AirLife™AIRLIFELYZ2025-02-14
20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
20197344098160SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098177SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
20197344098191SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-26
10860011916618Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916625Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916632Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916649Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10860011916656Medzah Stretch Vinyl Exam GloveMedzah IndustriesLYZ2024-07-19
10810141931265VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931272VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931289VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931296VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10810141931302VIVIT SupplyVivit Supply LLCLYZ2024-05-18
10097604870006Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870013Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870020Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870037Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10097604870044Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYZ2024-01-19
10755676000843ADI MedicalADI MedicalLYZ2023-11-27
10755676000850ADI MedicalADI MedicalLYZ2023-11-27
10755676000867ADI MedicalADI MedicalLYZ2023-11-27
10755676001482ADI MedicalADI MedicalLYZ2023-11-27
10755676001499ADI MedicalADI MedicalLYZ2023-11-27
10755676001512ADI MedicalADI MedicalLYZ2023-11-27
10813172024609DermAssist®INNOVATIVE HEALTHCARE CORPORATIONLYZ2023-09-01