FDA.reportPublic FDA data

Black Cobra

Primary DI
00850005229308
Brand
Black Cobra
Company
Medgluv Inc.
Model
MG59200
Catalog number
MG59200
Device description
Black Cobra Nitrile Exam Gloves, Thin Film, Black, Extra Small
Published
2023-10-31
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
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005229285PackageGS110In Commercial Distribution
00850005229308PrimaryGS10
00810145951347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005229285008500052292858500052292850850005229285
00850005229308008500052293088500052293080850005229308
00810145951347008101459513478101459513470810145951347

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.

Contacts#

Phone, Email table
PhoneEmail
+1(866)633-4588sales@medgluv.com

Regulatory Flags#

DUNS number
015809044
Device count
200
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005229001NitraSoftMG5250MG52502023-10-31
00850005229018NitraSoftMG5251MG52512023-10-31
00850005229025NitraSoftMG5252MG52522023-10-31
00850005229032NitraSoftMG5253MG52532023-10-31
00850005229049NitraSoftMG5254MG52542023-10-31
00850005229056NitraSoftMG5255MG52552023-10-31
00850005229124NitraGrip 300MG5400MG54002023-10-31
00850005229131NitraGrip 300MG5401MG54012023-10-31
00850005229148NitraGrip 300MG5402MG54022023-10-31
00850005229155NitraGrip 300MG5403MG54032023-10-31
00850005229162NitraGrip 300MG5404MG54042023-10-31
00850005229223NitraPlusMG5450MG54502023-10-31
00850005229254NitraPlusMG5453MG54532023-10-31
00850005229261NitraPlusMG5451MG54512023-10-31
00850005229278OysterSkinMG5304MG53042023-10-31
00850005229360NitraPlusMG5452MG54522023-10-31
00850005229483AmethystMG5801MG58012023-10-31
00850005229490AmethystMG5802MG58022023-10-31
00850005229506AmethystMG5803MG58032023-10-31
00850005229513AmethystMG5804MG58042023-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
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09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
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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
08859185209287Nitrylex 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
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12