Truline

GUDID 00850052602116

Arbill Industries, Inc.

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

• Primary Device ID: 00850052602116
• NIH Device Record Key: a1a6b84c-e5c7-4245-8860-4b08ed22695e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truline
• Version Model Number: A142344
• Company DUNS: 014631246
• Company Name: Arbill Industries, Inc.
• Device Count: 100
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850052602116 [Unit of Use]
GS1	10850052602113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [Truline]

• 10850052602007: A112341
• 00850052602239: A112354
• 00850052602222: A112353
• 00850052602208: A112351
• 00850052602154: A162344
• 00850052602147: A162343
• 00850052602130: A162342
• 00850052602123: A162341
• 00850052602116: A142344
• 00850052602109: A142343
• 00850052602093: A142342
• 00850052602086: A142341
• 00850052602079: A122344
• 00850052602062: A122343
• 00850052602055: A122342
• 00850052602048: A122341
• 00850052602031: A112344
• 00850052602024: A112343
• 00850052602017: A112342
• 00850052602192: A155024
• 00850052602215: A112352
• 00850052602185: A155023
• 00850052602178: A155022
• 00850052602161: A155021