FDA.reportPublic FDA data

Powder Free Nitrile Examination Gloves(White)

Primary DI
18938531860147
Brand
Powder Free Nitrile Examination Gloves(White)
Company
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
Model
KF-C-S
Published
2024-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K202356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202356000Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)Kanglongda Vietnam Protection Technology Company Limited2021-03-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18938531860147PrimaryGS10
08938531860140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1893853186014718938531860147
08938531860140089385318601408938531860140

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.

Regulatory Flags#

DUNS number
673067389
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18938531860017Powder Free Nitrile Examination Gloves(Blue)KF-A-XS2024-07-16
18938531860024Powder Free Nitrile Examination Gloves(Blue)KF-A-S2024-07-16
18938531860031Powder Free Nitrile Examination Gloves(Blue)KF-A-M2024-07-16
18938531860048Powder Free Nitrile Examination Gloves(Blue)KF-A-L2024-07-16
18938531860055Powder Free Nitrile Examination Gloves(Blue)KF-A-XL2024-07-16
18938531860062Powder Free Nitrile Examination Gloves(Blue)KF-A-XXL2024-07-16
18938531860079Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-XS2024-07-16
18938531860086Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-S2024-07-16
18938531860093Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-M2024-07-16
18938531860109Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-L2024-07-16
18938531860116Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-XL2024-07-16
18938531860123Powder Free Nitrile Examination Gloves(Violet Blue)KF-B-XXL2024-07-16
18938531860130Powder Free Nitrile Examination Gloves(White)KF-C-XS2024-07-16
18938531860154Powder Free Nitrile Examination Gloves(White)KF-C-M2024-07-16
18938531860161Powder Free Nitrile Examination Gloves(White)KF-C-L2024-07-16
18938531860178Powder Free Nitrile Examination Gloves(White)KF-C-XL2024-07-16
18938531860185Powder Free Nitrile Examination Gloves(White)KF-C-XXL2024-07-16
18938531860192Powder Free Nitrile Examination Gloves(Cobalt Blue)KF-D-XS2024-07-16
18938531860208Powder Free Nitrile Examination Gloves(Cobalt Blue)KF-D-S2024-07-16
18938531860215Powder Free Nitrile Examination Gloves(Cobalt Blue)KF-D-M2024-07-16

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