FDA.reportPublic FDA data

NeuSkin Ultra

Primary DI
00852039000526
Brand
NeuSkin Ultra
Company
Medgluv Inc.
Model
MG325L
Catalog number
MG325L
Device description
NeuSkin Ultra Vinyl Exam Gloves, Stretch, Large
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYZVinyl patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYZVinyl Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852039000526PackageGS110In Commercial Distribution
00852039000496PrimaryGS10
00810145950395Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852039000526008520390005268520390005260852039000526
00852039000496008520390004968520390004960852039000496
00810145950395008101459503958101459503950810145950395

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
015809044
Device count
100
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
false
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
00810145950975NeuMask PinkMGM103MGM1032026-07-17
00850005229728NeuMask OrangeMGM102MGM1022026-07-17
00850005229803NeulynxMG57500MG575002026-07-17
00850005229810NeulynxMG57501MG575012026-07-17
00850005229827NeulynxMG57502MG575022026-07-17
00850005229834NeulynxMG57503MG575032026-07-17
00850005229841NeulynxMG57504MG575042026-07-17
00810145952054NeuSkin ClearMG3000MG30002026-06-29
00810145952061NeuSkin ClearMG3001MG30012026-06-29
00810145952078NeuSkin ClearMG3002MG30022026-06-29
00810145952085NeuSkin ClearMG3003MG30032026-06-29
00810145952092NeuSkin ClearMG3004MG30042026-06-29
00810145952108NeuleafMG57700MG577002026-06-29
00810145952115NeuleafMG57701MG577012026-06-30
00810145952122NeuleafMG57702MG577022026-06-30
00810145952139NeuleafMG57703MG577032026-06-30
00810145952146NeuleafMG57704MG577042026-06-30
00810145952429NitraGrip Pro 100MG5009XP1MG5009XP12026-06-30
00810145952436NitraGrip Pro 100MG5009XP2MG5009XP22026-06-30
00810145952443NitraGrip Pro 100MG5009XP3MG5009XP32026-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536905610BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905627BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905634BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905641BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00199536905658BluelineTransparent Supply Solutions Ltd.LYZ2026-08-07
00850084857218MedClickMedClick LLCLYZ2026-07-22
00850084857225MedClickMedClick LLCLYZ2026-07-22
00850084857232MedClickMedClick LLCLYZ2026-07-22
00850084857249MedClickMedClick LLCLYZ2026-07-22
00850084857256MedClickMedClick LLCLYZ2026-07-22
00850084857263MedClickMedClick LLCLYZ2026-07-22
00850084857270MedClickMedClick LLCLYZ2026-07-22
00850084857287MedClickMedClick LLCLYZ2026-07-22
00850084857294MedClickMedClick LLCLYZ2026-07-22
00850084857300MedClickMedClick LLCLYZ2026-07-22
00850084857317MedClickMedClick LLCLYZ2026-07-22
00850084857324MedClickMedClick LLCLYZ2026-07-22
00080196515939CURADMEDLINE INDUSTRIES, INC.LYZ2026-07-06
00810145952054NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952061NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952078NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952085NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00810145952092NeuSkin ClearMedgluv Inc.LYZ2026-06-29
00713733712835MeijerMEIJER, INC.LYZ2026-06-05
10840330701911ProCureTwin Med, LLCLYZ2026-05-27
10840330701928ProCureTwin Med, LLCLYZ2026-05-27
10840330701935ProCureTwin Med, LLCLYZ2026-05-27
10840330701942ProCureTwin Med, LLCLYZ2026-05-27
10840330701959ProCureTwin Med, LLCLYZ2026-05-27
10840330701966ProCureTwin Med, LLCLYZ2026-05-27