FDA.reportPublic FDA data

VIVIT Supply

Primary DI
10810141931135
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
20543
Device description
Complete with Clean Reach Zero Nitrile Medical Examination Gloves, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Fentanyl Rated, Blue, Medium
Published
2023-10-16
Public version status
Update
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
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141931132PackageGS110In Commercial Distribution
10810141931135PrimaryGS10
00810141931138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193113220810141931132
1081014193113510810141931135
00810141931138008101419311388101419311380810141931138

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Regulatory Flags#

DUNS number
119042597
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
10810141931111VIVIT Supply205412023-10-16
10810141931128VIVIT Supply205422023-10-16
10810141931142VIVIT Supply205442023-10-16
10810141931159VIVIT Supply205452023-10-16
10810141930695VIVIT Supply206252023-09-16
10810141930701VIVIT Supply206242023-09-16
10810141930718VIVIT Supply206232023-09-16
10810141930725VIVIT Supply206222023-09-16
10810141930732VIVIT Supply206212023-09-16
10810141930893VIVIT Supply10116PM2023-09-15
10810141931012VIVIT Supply11111EM2023-12-15
10810141931500VIVIT Supply359112024-05-17
10810141931753VIVIT Supply206262024-04-26
10810141932910VIVIT Supply372SL2024-10-04
10810141933399VIVIT Supply/Caracal201452025-08-07
10810141933740VIVIT Supply205512026-02-03
10810141933757VIVIT Supply205522026-02-03
10810141933764VIVIT Supply205532026-02-03
10810141933771VIVIT Supply205542026-02-03
10810141933788VIVIT Supply205552026-02-03

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Primary DI, Brand, Company table
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00860010400906LuvatekR&C Imports LLCLZA2026-07-29
00860010400920LuvatekR&C Imports LLCLZA2026-07-29
00860010400937LuvatekR&C Imports LLCLZA2026-07-29
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
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