PROFENCE Nitrile Powder Free Examination Gloves

Primary DI
19551007775616
Brand
PROFENCE Nitrile Powder Free Examination Gloves
Company
HARTALEGA NGC SDN. BHD.
Model
NITRILE VB35202
Device description
S - PROFENCE Nitrile Powder Free Examination Gloves
Published
2022-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19551007775616PackageGS110In Commercial Distribution
09551007775619PrimaryGS10
09551007775824Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955100777561619551007775616
09551007775619095510077756199551007775619
09551007775824095510077758249551007775824

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
865807689
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19551017622504PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352012023-08-23
19551017622511PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352022023-08-23
19551017622528PROFENCE BLUE BIODEGRADABLENITRILE BDGVB352032023-08-23
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

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