FDA.reportPublic FDA data

NeoSkin

Primary DI
00893257001797
Brand
NeoSkin
Company
Medgluv Inc.
Model
MGS8884
Catalog number
MGS8884
Device description
NeoSkin Neoprene Surgical, Sterile, XC, Green, Extra Large (9.5)
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGOSurgeon's gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893257001797PackageGS14In Commercial Distribution
00893257001582PrimaryGS10
00810145951873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893257001797008932570017978932570017970893257001797
00893257001582008932570015828932570015820893257001582
00810145951873008101459518738101459518730810145951873

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene surgical glove, non-powderedA device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
015809044
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005229063NitraSoftMG5250MG52502023-10-31
00850005229070NitraSoftMG5251MG52512023-10-31
00850005229087NitraSoftMG5252MG52522023-10-31
00850005229094NitraSoftMG5253MG52532023-10-31
00850005229100NitraSoftMG5254MG52542023-10-31
00850005229117NitraSoftMG5255MG52552023-10-31
00850005229179NitraGrip 300MG5400MG54002023-10-31
00850005229186NitraGrip 300MG5401MG54012023-10-31
00850005229193NitraGrip 300MG5402MG54022023-10-31
00850005229209NitraGrip 300MG5403MG54032023-10-31
00850005229216NitraGrip 300MG5404MG54042023-10-31
00850005229230NitraPlusMG5450MG54502023-10-31
00893257001490NitraPlusMG5453MG54532023-10-31
00893257001902NitraPlusMG5451MG54512023-10-31
00893257001742OysterSkinMG5304MG53042023-10-31
00850005229285Black CobraMG59200MG592002023-10-31
00893257001896NitraPlusMG5452MG54522023-10-31
00850005229520AmethystMG5801MG58012023-10-31
00850005229537AmethystMG5802MG58022023-10-31
00850005229544AmethystMG5803MG58032023-10-31

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