Powder Free Nitrile Examination Gloves(White)

Primary DI
08938531860171
Brand
Powder Free Nitrile Examination Gloves(White)
Company
KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED
Model
KF-C-XL
Published
2024-07-16
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

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
18938531860178PrimaryGS10
08938531860171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1893853186017818938531860178
08938531860171089385318601718938531860171

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
673067389
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
false
No natural rubber latex
false
Sterilization required before use
false

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
18938531860147Powder Free Nitrile Examination Gloves(White)KF-C-S2024-07-16
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

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