791965

GUDID B340791965XL1

Latex Powder Free Exam Glove - XLarge

IMPACT PRODUCTS, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: B340791965XL1
• NIH Device Record Key: 31447557-7cd8-4a20-84b3-9c8bfbbf2639
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 791965XL
• Catalog Number: 791965
• Company DUNS: 005052360
• Company Name: IMPACT PRODUCTS, LLC
• Device Count: 1
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B340791965XL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982872

FDA Product Code

• LYZ: Vinyl 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: 2020-07-03
• Device Publish Date: 2020-06-25

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