FDA.reportPublic FDA data

Ideal

Primary DI
00847212008321
Brand
Ideal
Company
Elara Foodservice Disposables LLC
Model
902999
Catalog number
ID-NTBLK-XL
Device description
Black Nitrile Exam 3.5g Glove XL
Published
2023-01-12
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847212008321PrimaryGS10
30847212008339Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847212008321008472120083218472120083210847212008321
3084721200833930847212008339

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.

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
00847212007638Elara BrandsFED5012024-02-05
00847212007652Elara BrandsFED5022024-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10076490456525TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456532TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456549TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
09555002101053AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101060AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101428AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101442AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101558AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101589AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101596AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
G331COAP215S21Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP220S2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP315M2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP330M2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP415L2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP440L2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP515XL2Technigrip Powder Free Latex Exam GlovesTotal Source ManufacturingLYY2023-12-13
G331COAP550XL2SureGrip Latex Powder Free Exam GlovesTotal Source ManufacturingLYY2023-12-13
09551006060129RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24
09551006060136RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24
09551006060143RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24