FDA.reportPublic FDA data

Nitrylex classic blue chemo

Primary DI
08859185209256
Brand
Nitrylex classic blue chemo
Company
MERCATOR MEDICAL (THAILAND) LIMITED
Model
00
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobialSize: SPack: 100 pieces/inner box
Published
2026-03-26
Public version status
New
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
K251141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251141000Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl CitrateMercator Medical (Thailand), Ltd.2025-11-17LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859185209256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859185209256088591852092568859185209256

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit100 Degrees Fahrenheit

Regulatory Flags#

DUNS number
671647476
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859185202172mCare Diamond Orange002026-03-26
08859185202189mCare Diamond Orange002026-03-26
08859185202196mCare Diamond Orange002026-03-26
08859185202202mCare Diamond Orange002026-03-26
08859185202219mCare Diamond Orange002026-03-26
08859185209249Nitrylex classic blue chemo002026-03-26
08859185209263Nitrylex classic blue chemo002026-03-26
08859185209270Nitrylex classic blue chemo002026-03-26
08859185209287Nitrylex classic blue chemo002026-03-26
08859185209294Nitrylex black chemo002026-03-26
08859185209300Nitrylex black chemo002026-03-26
08859185209317Nitrylex black chemo002026-03-26
08859185209324Nitrylex black chemo002026-03-26
08859185209331Nitrylex black chemo002026-03-26
18859185202179mCare Diamond Orange002026-03-26
18859185202186mCare Diamond Orange002026-03-26
18859185202193mCare Diamond Orange002026-03-26
18859185202209mCare Diamond Orange002026-03-26
18859185202216mCare Diamond Orange002026-03-26
18859185209246Nitrylex classic blue chemo002026-03-26

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