Blue Nitrile Examination Gloves Powder Free

Primary DI
08859705100049
Brand
Blue Nitrile Examination Gloves Powder Free
Company
THAI RUBBER GLOVES COMPANY LIMITED - BRANCH
Model
Nitrile Blue
Device description
Nitrile Blue Powder free examination gloves
Published
2022-11-03
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213075000Goody Gloves, Wincare, TBG GlovesThai Rubber Gloves Co., Ltd.2022-01-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859705100046PackageGS1100In Commercial Distribution
08859705100049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885970510004618859705100046
08859705100049088597051000498859705100049

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.

Contacts#

Phone, Email table
PhoneEmail
+6621306356chalongkwan@thaitex.com

Regulatory Flags#

DUNS number
661782138
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859705100025Latex Examination Powder Free GlovesLatex White2022-11-03
18859705100022Latex Examination Powder Free GlovesLatex White2022-11-03
18859705100046Blue Nitrile Examination Gloves Powder FreeNitrile Blue2022-11-03

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