N300 35-1553

GUDID 10816419020716

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

Primary Device ID	10816419020716
NIH Device Record Key	1e73d1b1-64ee-44ed-87f5-3faca8e8ac1b
Commercial Distribution Status	In Commercial Distribution
Brand Name	N300
Version Model Number	35-1553
Catalog Number	35-1553
Company DUNS	016765988
Company Name	Ismile Dental Products, Inc.
Device Count	300
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
GS1	00816419020719 [Primary]
GS1	10816419020716 [Package] Contains: 00816419020719 Package: case [10 Units] In Commercial Distribution
GS1	20816419020713 [Unit of Use]

LZA	Polymer Patient Examination Glove

Steralize Prior To Use	false
Device Is Sterile	false

10816419020730	N300 Powder Free Nitrile Exam Gloves, X-Large
10816419020723	N300 Powder Free Nitrile Exam Gloves, Large
10816419020716	N300 Powder Free Nitrile Exam Gloves, Medium
10816419020709	N300 Powder Free Nitrile Exam Gloves, Small
10816419020693	N300 Powder Free Nitrile Exam Gloves, X-Small