FDA.reportPublic FDA data

NITRILECARE PREMIUM

Primary DI
09551006060822
Brand
NITRILECARE PREMIUM
Company
CAREGLOVE GLOBAL SDN. BHD.
Model
Nitrile XXL gloves
Device description
Powder Free Nitrile Examination Gloves, Blue Chemotest - XXL gloves
Published
2024-03-08
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211666000Powder Free Nitrile Examination Gloves, Blue ChemotestCareglove Global Sdn. Bhd.2022-01-09LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09551006060839PackageGS110In Commercial Distribution
09551006060822PrimaryGS10
09551006061492Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09551006060839095510060608399551006060839
09551006060822095510060608229551006060822
09551006061492095510060614929551006061492

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
+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
No 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
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
09551006061379NITRILE EXAMINATION MULTICOLOR PFNitrile L gloves2024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZC2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01