FDA.reportPublic FDA data

PROFENCE BLUE BIODEGRADABLE

Primary DI
19551017622528
Brand
PROFENCE BLUE BIODEGRADABLE
Company
HARTALEGA NGC SDN. BHD.
Model
NITRILE BDGVB35203
Published
2023-08-23
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
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
29551017622525PackageGS110In Commercial Distribution
19551017622528PrimaryGS10
09551017622521Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2955101762252529551017622525
1955101762252819551017622528
09551017622521095510176225219551017622521

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.

Contacts#

Phone, Email table
PhoneEmail
+60387073000liyana.harun@hartalega.com.my

Regulatory Flags#

DUNS number
865807689
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19551017622504PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352012023-08-23
19551017622511PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352022023-08-23
19551017622535PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352042023-08-23
19551017622542PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352052023-08-23
29551017622501PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352012023-08-23
29551017622518PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352022023-08-23
29551017622525PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352032023-08-23
29551017622532PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352042023-08-23
29551017622549PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352052023-08-23
09551007775602PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352012022-04-04
09551007775619PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352022022-04-04
09551007775626PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352032022-04-04
09551007775633PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352042022-04-04
09551007775640PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352052022-04-04
09551007775671PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB351012022-04-04
09551007775688PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB351022022-04-04
09551007775695PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB351032022-04-04
09551007775701PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB351042022-04-04
09551007775718PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB351052022-04-04
19551007775609PROFENCE Nitrile Powder Free Examination GlovesNITRILE VB352012022-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23
00755676003021mvetADI MedicalLZA2026-10-23
00755676003052mvetADI MedicalLZA2026-10-23