FDA.reportPublic FDA data

Elara Brands

Primary DI
00847212007638
Brand
Elara Brands
Company
Elara Foodservice Disposables LLC
Model
FED501
Device description
Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size small
Published
2024-02-05
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
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153028000Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co. , Ltd.2016-02-05LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847212007638PrimaryGS10
20847212007908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847212007638008472120076388472120076380847212007638
2084721200790820847212007908

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
010850179
Device count
100
DM exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847212008604Elara BrandsS-MND2012026-02-13
10847212008601Elara BrandsS-MND2012026-02-13
00847212008444Elara BrandsMND2012024-05-14
00847212008451Elara BrandsMND2022024-05-14
00847212008468Elara BrandsMND2032024-05-14
00847212008475Elara BrandsMND2042024-05-14
00847212008482Elara BrandsMND201BK2024-05-14
00847212008499Elara BrandsMND202BK2024-05-14
00847212008505Elara BrandsMND203BK2024-05-14
00847212008512Elara BrandsMND204BK2024-05-14
20847212008448Elara BrandsMND2012024-05-14
20847212008455Elara BrandsMND2022024-05-14
20847212008462Elara BrandsMND2032024-05-14
20847212008479Elara BrandsMND2042024-05-14
20847212008486Elara BrandsMND201BK2024-05-14
20847212008493Elara BrandsMND202BK2024-05-14
20847212008509Elara BrandsMND203BK2024-05-14
20847212008516Elara BrandsMND204BK2024-05-14
00847212007652Elara BrandsFED5022024-02-05
00847212007669Elara BrandsFED5032024-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27
10840330701973ProCureTwin Med, LLCLYZ2026-05-27
10840330701980ProCureTwin Med, LLCLYZ2026-05-27
10840330701997ProCureTwin Med, LLCLYZ2026-05-27
10840330702253ProCureTwin Med, LLCLYZ2026-05-27
10840330702260ProCureTwin Med, LLCLYZ2026-05-27
10840330702277ProCureTwin Med, LLCLYZ2026-05-27
10840330702284ProCureTwin Med, LLCLYZ2026-05-27
10840330705162ProCureTwin Med, LLCLYZ2026-05-27
10840330705179ProCureTwin Med, LLCLYZ2026-05-27
10840330705186ProCureTwin Med, LLCLYZ2026-05-27
10840330705193ProCureTwin Med, LLCLYZ2026-05-27
10840330705209ProCureTwin Med, LLCLYZ2026-05-27
10840330705216ProCureTwin Med, LLCLYZ2026-05-27
10840330705223ProCureTwin Med, LLCLYZ2026-05-27
10840330705230ProCureTwin Med, LLCLYZ2026-05-27
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