Toptolife 141404055

GUDID 20850036987127

Nitrile Exam Gloves, Nitrile Extended Cuff, XL

Toptolife, LLC

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

• Primary Device ID: 20850036987127
• NIH Device Record Key: 0a509417-bd4b-48a3-b741-4dc11e973d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Toptolife
• Version Model Number: 141404055
• Catalog Number: 141404055
• Company DUNS: 118666048
• Company Name: Toptolife, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00850036987123 [Unit of Use]
GS1	10850036987120 [Primary]
GS1	20850036987127 [Package]; Contains: 10850036987120; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171873

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [Toptolife]

• 20850036987226: Nitrile Exam Gloves, Chemo Extended Cuff, XL
• 20850036987219: Nitrile Exam Gloves, Chemo Extended Cuff, L
• 20850036987202: Nitrile Exam Gloves, Chemo Extended Cuff, M
• 20850036987196: Nitrile Exam Gloves, Chemo Extended Cuff, S
• 20850036987189: Nitrile Exam Gloves, Chemo Extended Cuff, XS
• 20850036987172: Nitrile Exam Gloves, Chemo, XL
• 20850036987165: Nitrile Exam Gloves, Chemo, L
• 20850036987158: Nitrile Exam Gloves, Chemo, M
• 20850036987141: Nitrile Exam Gloves, Chemo, S
• 20850036987134: Nitrile Exam Gloves, Chemo, XS
• 20850036987127: Nitrile Exam Gloves, Nitrile Extended Cuff, XL
• 20850036987110: Nitrile Exam Gloves, Nitrile Extended Cuff, L
• 20850036987103: Nitrile Exam Gloves, Nitrile Extended Cuff, M
• 20850036987097: Nitrile Exam Gloves, Nitrile Extended Cuff, S
• 20850036987080: Nitrile Exam Gloves, Nitrile Extended Cuff, XS
• 00850036987079: Nitrile Exam Gloves, Nitrile, XXL
• 00850036987062: Nitrile Exam Gloves, Nitrile, XL
• 00850036987055: Nitrile Exam Gloves, Nitrile, L
• 00850036987048: Nitrile Exam Gloves, Nitrile, M
• 00850036987031: Nitrile Exam Gloves, Nitrile, S
• 00850036987024: Nitrile Exam Gloves, Nitrile, XS
• 00850036987284: Procedure Masks, Ear loops, Blue; (ASTM Level 1)