FDA.reportPublic FDA data

RUBBERCARE LATEX PF

Primary DI
09551006060143
Brand
RUBBERCARE LATEX PF
Company
CAREGLOVE GLOBAL SDN. BHD.
Model
Latex M gloves
Device description
Latex Examination Gloves Powder Free Medium Gloves
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161833000LATEX EXAMINATION GLOVE POWDER FREECareglove Global Sdn. Bhd.2017-05-23LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551006060198PackageGS110In Commercial Distribution
09551006060143PrimaryGS10
09551006061461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551006060198095510060601989551006060198
09551006060143095510060601439551006060143
09551006061461095510060614619551006061461

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+6067292130farhana.aqilah@careplus.com

Regulatory Flags#

DUNS number
865779649
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09551006061249CHLOROPRENE EXAMINATION PF Chloroprene XS gloves2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF Chloroprene S gloves2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF Chloroprene M gloves2024-03-08
09551006061270CHLOROPRENE EXAMINATION PF Chloroprene L gloves2024-03-08
09551006061287CHLOROPRENE EXAMINATION PF Chloroprene XL gloves2024-03-08
09551006060525NITRILECARE PREMIUM Nitrile XS gloves2024-03-08
09551006060532NITRILECARE PREMIUM Nitrile S gloves2024-03-08
09551006060549NITRILECARE PREMIUM Nitrile M gloves2024-03-08
09551006060556NITRILECARE PREMIUM Nitrile L gloves2024-03-08
09551006060563NITRILECARE PREMIUMNitrile XL gloves2024-03-08
09551006060624NITRILECARE ELITEXS gloves2024-03-08
09551006060631NITRILECARE ELITES gloves2024-03-08
09551006060648NITRILECARE ELITEM gloves2024-03-08
09551006060655NITRILECARE ELITEL gloves2024-03-08
09551006060662NITRILECARE ELITEXL gloves2024-03-08
09551006060822NITRILECARE PREMIUM Nitrile XXL gloves2024-03-08
09551006061225NITRILECARE ELITE XXL gloves2024-03-08
09551006061348NITRILE EXAMINATION MULTICOLOR PFNitrile XS gloves2024-03-08
09551006061355NITRILE EXAMINATION MULTICOLOR PFNitrile S gloves2024-03-08
09551006061362NITRILE EXAMINATION MULTICOLOR PFNitrile M gloves2024-03-08

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
09551006060150RUBBERCARE LATEX PFCAREGLOVE GLOBAL SDN. BHD.LYY2023-11-24