UNC

GUDID 00850045738037

UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Medium

The University of North Carolina Health System

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00850045738037
NIH Device Record Key70e252b0-9c3c-4d38-949f-af8627ec32bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNC
Version Model NumberGLVUNCM
Company DUNS926678491
Company NameThe University of North Carolina Health System
Device Count200
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045738037 [Unit of Use]
GS110850045738034 [Primary]
GS120850045738031 [Package]
Contains: 10850045738034
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-14
Device Publish Date2022-11-04

On-Brand Devices [UNC]

20850045738000UNC Overhead SMS Gown, Thumbloops, Open Back, Yellow, Universal
00850045738051UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, X-Large
00850045738044UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Large
00850045738037UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Medium
00850045738020UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Small
00850045738013UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, X-Small
20850045738062UNC Overhead SMS Gown, Thumbloops with Elastic Cuff, Open Back, Yellow, Universal
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