KIMTECH PURPLE NITRILE-XTRA EXAM GLOVES (S) 50601-54

GUDID 10036000506010

Examination Gloves

KIMBERLY-CLARK GLOBAL SALES, LLC

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

• Primary Device ID: 10036000506010
• NIH Device Record Key: 4049e9f4-029f-4f4e-a0a5-7f7789fdf967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIMTECH PURPLE NITRILE-XTRA EXAM GLOVES (S)
• Version Model Number: 50601
• Catalog Number: 50601-54
• Company DUNS: 830997032
• Company Name: KIMBERLY-CLARK GLOBAL SALES, LLC
• Device Count: 50
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com
• Phone: +1(888)346-4652
• Email: info@kcprofessional.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sources of light and radiation; Protect from moisture.
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036000506013 [Primary]
GS1	10036000506010 [Package]; Contains: 00036000506013; Package: Case [10 Units]; In Commercial Distribution
GS1	90036000506016 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113423
• Premarket Notification: K162294

FDA Product Code

• LZC: Patient examination glove, specialty

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: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [KIMTECH PURPLE NITRILE-XTRA EXAM GLOVES (S)]

• 10036015506012: Examination Gloves
• 10036000506010: Examination Gloves