FDA.reportPublic FDA data

ORCARE SURGICAL LATEX PF

Primary DI
09551006061003
Brand
ORCARE SURGICAL LATEX PF
Company
CAREGLOVE GLOBAL SDN. BHD.
Model
5.5
Device description
Sterile Latex Surgical Gloves, Powder Free
Published
2023-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190241000Sterile Latex Surgical Glove, Powder FreeCareglove Global Sdn. Bhd.2019-12-30KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551006061034PackageGS14In Commercial Distribution
09551006061003PrimaryGS10
09551006061478Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551006061034095510060610349551006061034
09551006061003095510060610039551006061003
09551006061478095510060614789551006061478

Contacts#

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

Regulatory Flags#

DUNS number
865779649
Device count
50
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07333350119621Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350176181Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350407926Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350581305Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350696177Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350861582Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350974121Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350999124Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
10809160542125HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
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00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
10809160538968HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-24
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
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10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03