FDA.reportPublic FDA data

VIVIT

Primary DI
20810084210271
Brand
VIVIT
Company
1. Vivit International Inc
Model
25914
Device description
Extended Cuff Nitrile Examination Glove, Powder-Free, Textured Fingertips, Chemotherapy Drug Tested, Extended Cuff, Blue, Large
Published
2021-10-30
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810084210271PackageGS110In Commercial Distribution
10810084210274PrimaryGS10
00810084210277Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081008421027120810084210271
1081008421027410810084210274
00810084210277008100842102778100842102770810084210277

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
815240958
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
00810084210000VIVIT8440FW2022-10-28
20810084210028VIVIT8441FW2022-10-28
20810084210455VIVIT1130HW2022-10-28
20810084210462VIVIT1131HW2022-10-28
20810084210011VIVIT10112EM2021-10-30
20810084210035VIVIT10111EM2021-10-30
00810084210048VIVIT30114EM2021-10-30
20810084210059VIVIT31314EM2021-10-30
00810084210062VIVIT313141EMV2021-10-30
20810084210073VIVIT10311TM2021-10-30
20810084210080VIVIT10215TM2021-10-30
20810084210097VIVIT30215TM2021-10-30
20810084210103VIVIT10333TM2021-10-30
20810084210110VIVIT11311TM2021-10-30
20810084210127VIVIT13313TM2021-10-30
20810084210134VIVIT12313TM2021-10-30
20810084210141VIVIT11215TM2021-10-30
20810084210158VIVIT30314TM2021-10-30
20810084210165VIVIT31314TM2021-10-30
20810084210172VIVIT313241TMV2021-10-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015678959UCKER1ST TRY, CORPLZA2026-05-22
00860015678966UCKER1ST TRY, CORPLZA2026-05-22
00860015678973UCKER1ST TRY, CORPLZA2026-05-22
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
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