TOUCH Chemo Tested Nitrile Exam Glove

GUDID 00850014448240

TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Large

LABOTEK GROUP CORP

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

• Primary Device ID: 00850014448240
• NIH Device Record Key: a2869e25-bdc4-4d47-ba21-33ff456154fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOUCH Chemo Tested Nitrile Exam Glove
• Version Model Number: PRG-CTN-L
• Company DUNS: 117338398
• Company Name: LABOTEK GROUP CORP
• Device Count: 200
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com
• Phone: 7877851555
• Email: e.colon@labotekgroup.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014448233 [Primary]
GS1	00850014448240 [Package]; Contains: 00850014448233; Package: Box [200 Units]; In Commercial Distribution
GS1	10850014448230 [Unit of Use]
GS1	10850014448247 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170136

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: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [TOUCH Chemo Tested Nitrile Exam Glove]

• 00850014448264: TOUCH Nitrile Examination Glove, Chemotherapy Tested, Size X-Large
• 00850014448240: TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Large
• 00850014448226: TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Medium
• 00850014448202: TOUCH Nitrile Exam Glove, Chemotherapy Tested, Size Small
• 00850014448189: TOUCH Nitrile Examination Glove, Chemotherapy Tested, Size X-Small