FDA.reportPublic FDA data

Hero

Primary DI
00653195430055
Brand
Hero
Company
TRANZONIC ACQUISITION CORP.
Model
HER005
Catalog number
HER005
Device description
HERO® Disposable Latex Exam Gloves, Powder Free, Blue, 14 mil, Medium, 50/bx, 10 bxs/cs
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653195430052PackageGS110In Commercial Distribution
00653195430055PrimaryGS10
70653195430054Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065319543005210653195430052
00653195430055006531954300556531954300550653195430055
7065319543005470653195430054

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8003219832info@hospeco.com

Regulatory Flags#

DUNS number
090125555
Device count
50
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075289122392OPTIFY GL-NCF265BFXS GL-NCF265BFXS 2020-04-20
00075289122408OPTIFY GL-NCF265BFS GL-NCF265BFS 2020-04-20
00075289122415OPTIFY GL-NCF265BFM GL-NCF265BFM 2020-04-20
00075289122422OPTIFY GL-NCF265BFL GL-NCF265BFL 2020-04-20
00075289122439OPTIFY GL-NCF265BFX GL-NCF265BFX 2020-04-20
00075289122446KODA GL-NCF235BKFXS GL-NCF235BKFXS 2020-04-20
00075289122453KODA GL-NCF235BKFS GL-NCF235BKFS 2020-04-20
00075289122460KODA GL-NCF235BKFM GL-NCF235BKFM 2020-04-20
00075289122477KODA GL-NCF235BKFL GL-NCF235BKFL 2020-04-20
00075289122484KODA GL-NCF235BKFX GL-NCF235BKFX 2020-04-20
00075289122491Enov-8 GL-NCF225BFXS GL-NCF225BFXS 2020-04-27
00075289122507Enov-8 GL-NCF225BFS GL-NCF225BFS 2020-04-20
00075289122514Enov-8 GL-NCF225BFM GL-NCF225BFM 2020-04-20
00075289122521Enov-8 GL-NCF225BFL GL-NCF225BFL 2020-04-20
00075289122538Enov-8 GL-NCF225BFX GL-NCF225BFX 2020-04-20
00075289122545OPTIFY GL-NCF265BFXX GL-NCF265BFXX 2020-04-20
00075289122552KODA GL-NCF235BKFXX GL-NCF235BKFXX 2020-04-20
00075289127328ProWorksGL-N108EPF-SMGL-N108EPF-SM2020-04-20
00075289127335ProWorksGL-N108EPF-MEDGL-N108EPF-MED2020-04-20
00075289127342ProWorksGL-N108EPF-LGGL-N108EPF-LG2020-04-20

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