NEXT-GEN 44-109M

GUDID 10850043811289

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

Genesee Scientific Holdings, LLC

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

• Primary Device ID: 10850043811289
• NIH Device Record Key: 700f35f4-e35c-40a2-95d2-66fd8053de19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXT-GEN
• Version Model Number: 44-109M
• Catalog Number: 44-109M
• 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	00850043811282 [Primary]
GS1	00850043811725 [Package]; Contains: 00850043811282; Package: [10 Units]; In Commercial Distribution
GS1	10850043811289 [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

On-Brand Devices [NEXT-GEN]

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• 10850043811487: S-GEN Powder-Free Nitrile Examination Gloves, Size XL, 200
• 10850043811470: S-GEN Powder-Free Nitrile Examination Gloves, Size S, 200
• 10850043811463: S-GEN Powder-Free Nitrile Examination Gloves, Size M, 200
• 10850043811456: S-GEN Powder-Free Nitrile Examination Gloves, Size L, 200
• 10850043811449: N-GEN Powder-Free Nitrile Examination Gloves, Size XS, 100
• 10850043811432: N-GEN Powder-Free Nitrile Examination Gloves, Size XL, 100
• 10850043811425: N-GEN Powder-Free Nitrile Examination Gloves, Size S, 100
• 10850043811418: N-GEN Powder-Free Nitrile Examination Gloves, Size M, 100
• 10850043811401: N-GEN Powder-Free Nitrile Examination Gloves, Size L, 100
• 10850043811395: X-GEN Powder-Free Nitrile Examination Gloves, Size XS, 100
• 10850043811388: X-GEN Powder-Free Nitrile Examination Gloves, Size XL, 100
• 10850043811371: X-GEN Powder-Free Nitrile Examination Gloves, Size S, 100
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• 10850043811357: X-GEN Powder-Free Nitrile Examination Gloves, Size L, 100
• 10850043811340: E-GEN Powder-Free Latex Examination Gloves, Size XS, 100
• 10850043811333: E-GEN Powder-Free Latex Examination Gloves, Size XL, 100
• 10850043811326: E-GEN Powder-Free Latex Examination Gloves, Size S, 100
• 10850043811319: E-GEN Powder-Free Latex Examination Gloves, Size M, 100
• 10850043811296: Z-GEN Powder-Free Nitrile Examination Gloves, Size L, 100
• 10850043811289: Z-GEN Powder-Free Nitrile Examination Gloves, Size M, 100
• 10850043811272: Z-GEN Powder-Free Nitrile Examination Gloves, Size S, 100
• 10850043811265: Z-GEN Powder-Free Nitrile Examination Gloves, Size XL, 100
• 10850043811258: Z-GEN Powder-Free Nitrile Examination Gloves, Size XS, 100
• 00850043811909: X-GEN Powder-Free Nitrile Examination Gloves, Size XS, Black, 100
• 00850043811886: X-GEN Powder-Free Nitrile Examination Gloves, Size XL, Black, 100
• 00850043811862: X-GEN Powder-Free Nitrile Examination Gloves, Size S, Black, 100
• 00850043811848: X-GEN Powder-Free Nitrile Examination Gloves, Size M, Black, 100
• 10850043811814: X-GEN Powder-Free Nitrile Examination Gloves, Size L, Black, 100