FDA.reportPublic FDA data

PureOnyx

Primary DI
D79010681031
Brand
PureOnyx
Company
PURELIFE, LLC
Model
1068103
Catalog number
1068103
Device description
PureOnyx Black Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Textured fingertips, Black in color, Packaging contains recycled material
Published
2023-09-22
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
QDOFentanyl and other opioid protection glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79010681031PrimaryHIBCC0
D79010681030Unit of UseHIBCC0

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(877)777-3303sales@purelifedental.com

Regulatory Flags#

DUNS number
828690904
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D79011549031PureLife Dental115490311549032025-07-08
D79011549033PureLife Dental115490311549032025-07-08
D790106840110685011PureOrthoSense10684011068501106840110685012025-03-20
D790106840210685021PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685031PureOrthoSense10684031068503106840310685032025-03-20
D790106840410685041PureOrthoSense10684041068504106840410685042025-03-20
D790106840510685051PureOrthoSense10684051068505106840510685052025-03-20
D790106840110685010PureOrthoSense10684011068501106840110685012025-03-20
D790106840210685020PureOrthoSense10684021068502106840210685022025-03-20
D790106840310685030PureOrthoSense10684031068503106840310685032025-03-20
D790106840410685040PureOrthoSense10684041068504106840410685042025-03-20
D790106840510685050PureOrthoSense10684051068505106840510685052025-03-20
D79011130011PureLife+ Non-Woven Sponges111300111130012023-06-08
D79011130021PureLife+ Non-Woven Sponges111300211130022023-06-08
D79010811011PureLife Dental108110110811012020-05-13
D79010811021PureLife Dental108110210811022020-05-13
D79010811031PureLife Dental108110310811032020-05-13
D79010811041PureLife Dental108110410811042020-05-13
D79010840011PureLife+ Plastic Headrest Covers108400110840012023-06-08
D79010840021PureLife+ Plastic Headrest Covers108400210840022023-06-08

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