FDA.report

NitraGrip 12" Pair

Primary DI
00898110000702
Brand
NitraGrip 12" Pair
Company
Medgluv Inc.
Model
MGSE5122
Catalog number
MGSE5122
Device description
NitraGrip Nitrile Exam Gloves, Sterile Pairs, XC, Medium
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
LZCMedical Glove, Specialty

Product Code Classifications

CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00898110000702PackageGS14In Commercial Distribution
00898110000313PrimaryGS10
00810145951774Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00898110000702008981100007028981100007020898110000702
00898110000313008981100003138981100003130898110000313
00810145951774008101459517748101459517740810145951774

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

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00893257001902NitraPlusMG5451MG54512023-10-31
00893257001742OysterSkinMG5304MG53042023-10-31
00850005229285Black CobraMG59200MG592002023-10-31
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00850005229520AmethystMG5801MG58012023-10-31
00850005229537AmethystMG5802MG58022023-10-31
00850005229544AmethystMG5803MG58032023-10-31

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