PureOnyx 1068105

GUDID D79010681050

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Primary Device ID	D79010681050
NIH Device Record Key	3f032477-cdf2-4d82-b559-0eefb4b499c9
Commercial Distribution Status	In Commercial Distribution
Brand Name	PureOnyx
Version Model Number	1068105
Catalog Number	1068105
Company DUNS	828690904
Company Name	PURELIFE, LLC
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D79010681050 [Unit of Use]
HIBCC	D79010681051 [Primary]

LZA	Polymer patient examination glove

Steralize Prior To Use	false
Device Is Sterile	false

D79010681050	PureOnyx Black Nitrile Powder-Free, X-Large, Nitrile powder-free gloves, Textured fingertips, Bl
D79010681040	PureOnyx Black Nitrile Powder-Free, Large, Nitrile powder-free gloves, Textured fingertips, Blac
D79010681030	PureOnyx Black Nitrile Powder-Free, Medium, Nitrile powder-free gloves, Textured fingertips, Bla
D79010681020	PureOnyx Black Nitrile Powder-Free, Small, Nitrile powder-free gloves, Textured fingertips, Blac
D79010681010	PureOnyx Black Nitrile Powder-Free, X-Small, Nitrile powder-free gloves, Textured fingertips, Bl