Kimtech Prizm Xtra Neoprene Nitrile Exam Gloves (XL) 51954-00

GUDID 10036000519546

Examination Gloves

KIMBERLY-CLARK GLOBAL SALES, LLC

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

• Primary Device ID: 10036000519546
• NIH Device Record Key: 282ef1c9-cd8b-400a-b872-4191b000872e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kimtech Prizm Xtra Neoprene Nitrile Exam Gloves (XL)
• Version Model Number: 51954
• Catalog Number: 51954-00
• 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.
• 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
• 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	00036000519549 [Primary]
GS1	10036000519546 [Package]; Contains: 00036000519549; Package: Case [10 Units]; In Commercial Distribution
GS1	90036000519542 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202416

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: 2021-01-07
• Device Publish Date: 2020-12-30

Devices Manufactured by KIMBERLY-CLARK GLOBAL SALES, LLC

• 10036000628705 - Kimtech Element Nitrile Exam Gloves (XS): 2021-07-22 Examination Gloves
• 10036000628712 - Kimtech Element Nitrile Exam Gloves (S): 2021-07-22 Examination Gloves
• 10036000628729 - Kimtech Element Nitrile Exam Gloves (M): 2021-07-22 Examination Gloves
• 10036000628736 - Kimtech Element Nitrile Exam Gloves (L): 2021-07-22 Examination Gloves
• 10036000628743 - Kimtech Element Nitrile Exam Gloves (XL): 2021-07-22 Examination Gloves
• 10036000628606 - Kimtech Opal Nitrile Exam Gloves (XS): 2021-05-18 Examination Gloves
• 10036000628613 - Kimtech Opal Nitrile Exam Gloves (S): 2021-05-18 Examination Gloves
• 10036000628620 - Kimtech Opal Nitrile Exam Gloves (M): 2021-05-18 Examination Gloves