STARFLEX

GUDID 00860010196557

Starlion Electronics Distribution, LLC

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: 00860010196557
• NIH Device Record Key: 74239394-5e4e-4535-9f47-361e12c15d46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARFLEX
• Version Model Number: SF1-L-NTR-BLK
• Company DUNS: 118344564
• Company Name: Starlion Electronics Distribution, 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: true
• 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	00860010196540 [Primary]
GS1	00860010196557 [Package]; Contains: 00860010196540; Package: [10 Units]; In Commercial Distribution
GS1	10860010196547 [Unit of Use]

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 [STARFLEX]

• 00860010283677: SF2-XL-VNY-CLR
• 00860010283653: SF2-L-VNY-CLR
• 00860010283639: SF2-M-VNY-CLR
• 00860010283615: SF2-S-VNY-CLR
• 00860010196571: SF1-XL-NTR-BLK
• 00860010196557: SF1-L-NTR-BLK
• 00860010196533: SF1-M-NTR-BLK
• 00860010196519: SF1-S-NTR-BLK