BluTouch TNR 700L

GUDID 00860008185112

Glove, Nitrile, Large, Powder Free, 100/box

MERCEDES MEDICAL, LLC

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

• Primary Device ID: 00860008185112
• NIH Device Record Key: af93bb69-60ff-403d-9a2a-f91f5638485f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BluTouch
• Version Model Number: TNR 700L
• Catalog Number: TNR 700L
• Company DUNS: 834472680
• Company Name: MERCEDES MEDICAL, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008185112 [Primary]
GS1	10860008185119 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2023-05-23
• Device Publish Date: 2023-05-15

On-Brand Devices [BluTouch]

• 10860008185133: Gloves, Nitrile, X-Large, BluTouch, Powder Free, 100/Box
• 00860008185112: Glove, Nitrile, Large, Powder Free, 100/box