FDA.report

NitraSonic

Primary DI
00898110000009
Brand
NitraSonic
Company
Medgluv Inc.
Model
MGS5080
Catalog number
MGS5080
Device description
NItraSonic Nitrile Surgical Gloves, Sterile, XC, Size 8.0
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

Related Records

Contact Domains

Product Codes

CodeName
KGOSurgeon's gloves

Product Code Classifications

CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00898110000009PackageGS14In Commercial Distribution
00898110000054PrimaryGS10
00810145951552Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00898110000009008981100000098981100000090898110000009
00898110000054008981100000548981100000540898110000054
00810145951552008101459515528101459515520810145951552

GMDN Terms

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.

Sterilization Methods

Method

Contacts

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 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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