PureHorizon 1067305

GUDID D79010673053

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

Primary Device ID	D79010673053
NIH Device Record Key	2e8278b2-e5f2-4f45-a8ad-4947ddac3802
Commercial Distribution Status	In Commercial Distribution
Brand Name	PureHorizon
Version Model Number	1067305
Catalog Number	1067305
Company DUNS	828690904
Company Name	PURELIFE, LLC
Device Count	200
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	false
Serial Number	false
Manufacturing Date	false
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	D79010673050 [Unit of Use]
HIBCC	D79010673051 [Primary]
HIBCC	D79010673053 [Package] Contains: D79010673051 Package: Case [2000 Units] In Commercial Distribution

LZA	Polymer Patient Examination Glove

Steralize Prior To Use	false
Device Is Sterile	false

D79010673053	X-Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains rec
D79010673043	Large, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recyc
D79010673033	Medium, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recy
D79010673023	Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains recyc
D79010673013	X-Small, Very soft, stretchy nitrile, Textured fingertips, Blue in color, Packaging contains rec