No brand Name 4053G

GUDID 00634782100193

CPR Resuscitator Gloves only, Large

AMERICAN DIAGNOSTIC CORP

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

• Primary Device ID: 00634782100193
• NIH Device Record Key: 7b70c578-d67c-4ded-bb8c-7e43092e184b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No brand Name
• Version Model Number: 4053G
• Catalog Number: 4053G
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782100193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992686

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

Devices Manufactured by AMERICAN DIAGNOSTIC CORP

• 00634782602642 - Adscope®: 2024-06-03 ADSCOPE LE 603 Stethoscope,Adult 30", Surfs Up
• 00634782602659 - Adscope®: 2024-06-03 ADSCOPE LE 603 Stethoscope,Adult 30", Surfs Up, Tactical
• 00634782602666 - Adscope®: 2024-06-03 ADSCOPE LE 608 Conv Stethoscope,Adult 30", Surfs Up
• 00634782602673 - Adscope®: 2024-06-03 ADSCOPE LE 608 Conv Stethoscope,Adult 30", Surfs Up, Tactical
• 00634782602680 - Adscope®: 2024-06-03 ADSCOPE LE 615 Stethoscope,Adult 30", Surfs Up
• 00634782602697 - Adscope®: 2024-06-03 ADSCOPE LE 615 Stethoscope,Adult 30", Surfs Up, Tactical
• 00634782902728 - MiniMedicut™: 2024-06-03 MiniMedicut Shears,5-1/2", Frosted Kiwi, Zoll PL
• 00634782602734 - Pro's Combo™: 2024-05-24 Pro's Combo 768/603 Royal Blue,Adult,Royal Blue,LF, 353RB,301