FDA.reportPublic FDA data

VIVIT Supply

Primary DI
10810141931579
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
44913
Device description
Stealth Nitrile Medical Examination Gloves, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Fentanyl Rated, Black, Medium
Published
2024-05-18
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141931576PackageGS110In Commercial Distribution
10810141931579PrimaryGS10
00810141931572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193157620810141931576
1081014193157910810141931579
00810141931572008101419315728101419315720810141931572

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
100
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
10810141930008VIVIT Supply10112EM2023-09-15
10810141930015VIVIT Supply10111EM2023-09-15
10810141930022VIVIT Supply30114EM2023-09-15
10810141930039VIVIT Supply31314EM2023-09-15
10810141930046VIVIT Supply313141EMV2023-09-15
10810141930053VIVIT Supply10311TM2023-09-15
10810141930060VIVIT Supply10215TM2023-09-15
10810141930084VIVIT Supply10333TM2023-09-15
10810141930091VIVIT Supply11311TM2023-09-15
10810141930107VIVIT Supply13313TM2023-09-15
10810141930121VIVIT Supply11215TM2023-09-15
10810141930138VIVIT Supply30314TM2023-09-15
10810141930145VIVIT Supply31314TM2023-09-15
10810141930152VIVIT Supply313241TMV2023-09-15
10810141930169VIVIT Supply313242TMV2023-09-15
10810141930176VIVIT Supply130Y2023-09-10
10810141930183VIVIT Supply131Y2023-09-10
10810141930190VIVIT Supply230Y2023-09-10
10810141930206VIVIT Supply231Y2023-09-10
10810141930336VIVIT Supply205212023-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00196633795946Kirkland SignatureCostco Wholesale CorporationLZA2026-06-17
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
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00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
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00810194400148AiraAIRA, LLCLZA2026-01-16
00810194400193AiraAIRA, LLCLZA2026-01-16
00842942014154PRIMEDpriMED Medical Products IncLZC2025-11-18
00842942014154PRIMEDpriMED Medical Products IncLZA2025-11-18