FDA.reportPublic FDA data

NITRILECARE BLUE PF

Primary DI
09551006060044
Brand
NITRILECARE BLUE PF
Company
CAREGLOVE GLOBAL SDN. BHD.
Model
Nitrile XL gloves
Device description
Powder Free Nitrile Examination Gloves, Blue (colored) - XL gloves
Published
2023-11-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172015000POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)Careglove Global Sdn. Bhd.2017-09-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551006060044PackageGS110In Commercial Distribution
09551006060105PrimaryGS10
09551006061485Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551006060044095510060600449551006060044
09551006060105095510060601059551006060105
09551006061485095510060614859551006061485

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
+6067292130farhana.aqilah@careplus.com

Regulatory Flags#

DUNS number
865779649
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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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