FDA.reportPublic FDA data

nitrylex classic+

Primary DI
08859185201274
Brand
nitrylex classic+
Company
MERCATOR MEDICAL (THAILAND) LIMITED
Model
RD30246901_0001
Device description
Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XS Pack 100 pieces/ inner box
Published
2021-03-05
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
K172930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172930000mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd.2018-04-13LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08859185201274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08859185201274088591852012748859185201274

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
671647476
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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