790071

GUDID B3407900ML1

Large Synthetic Vinyl Powder Free Exam Glove

IMPACT PRODUCTS, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: B3407900ML1
• NIH Device Record Key: 3f07540a-239f-48c0-8082-66ff945930ee
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 790071M
• Catalog Number: 790071
• 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	B3407900ML1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2020-07-06
• Device Publish Date: 2020-06-26

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