No brand Name 4053G

GUDID 00634782100193

CPR Resuscitator Gloves only, Large

AMERICAN DIAGNOSTIC CORP

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00634782100193
NIH Device Record Key7b70c578-d67c-4ded-bb8c-7e43092e184b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNo brand Name
Version Model Number4053G
Catalog Number4053G
Company DUNS108999095
Company NameAMERICAN DIAGNOSTIC CORP
Device Count1
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com
Phone1-800-232-2670
Emailinfo@adctoday.com

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100634782100193 [Primary]

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 Date2023-12-19
Device Publish Date2023-12-11

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