FDA.reportPublic FDA data

Nitrylex classic blue chemo

Primary DI
08859185209287
Brand
Nitrylex classic blue chemo
Company
MERCATOR MEDICAL (THAILAND) LIMITED
Model
00
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobialSize: XLPack: 100 pieces/ inner boxes
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
08859185209287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859185209287088591852092878859185209287

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
08859185209256Nitrylex classic blue chemo002026-03-26
08859185209263Nitrylex classic blue chemo002026-03-26
08859185209270Nitrylex 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061270CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08