DURA-COR 4030XL

GUDID 30796326000954

EXAMINATION GLOVES LATEX POWDER FREE

International Sourcing Company, Inc.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 30796326000954
• NIH Device Record Key: a4089d58-abdb-4d7a-8d8e-1fd742236a7b
• Commercial Distribution Discontinuation: 2028-07-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURA-COR
• Version Model Number: 4030XL
• Catalog Number: 4030XL
• Company DUNS: 873018162
• Company Name: International Sourcing Company, Inc.
• Device Count: 500
• DM Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com
• Phone: 9014585030
• Email: rhonda.camp@cordovaisc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 30 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 30 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00796326000953 [Primary]
GS1	30796326000954 [Package]; Contains: 00796326000953; Package: [500 Units]; Discontinued: 2028-07-28; In Commercial Distribution
GS1	50796326000958 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192329

FDA Product Code

• LYY: Latex 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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [DURA-COR]

• 30796326000923: EXAMINATION GLOVES LATEX POWDER FREE
• 30796326000954: EXAMINATION GLOVES LATEX POWDER FREE
• 30796326000947: EXAMINATION GLOVES LATEX POWDER FREE
• 30796326000930: EXAMINATION GLOVES LATEX POWDER FREE