NEXT-GEN 44-109XL

GUDID 10850043811265

Z-GEN Powder-Free Nitrile Examination Gloves, Size XL, 100

Genesee Scientific Holdings, LLC

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

• Primary Device ID: 10850043811265
• NIH Device Record Key: dfb288b5-cbac-4412-b807-8ba35d1c004d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXT-GEN
• Version Model Number: 44-109XL
• Catalog Number: 44-109XL
• Company DUNS: 943016071
• Company Name: Genesee Scientific Holdings, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043811268 [Primary]
GS1	00850043811749 [Package]; Contains: 00850043811268; Package: [10 Units]; In Commercial Distribution
GS1	10850043811265 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171874

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: 2022-08-26
• Device Publish Date: 2022-08-18

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