791955

GUDID B340791955M1

Latex Powder Free Exam Glove - Medium

IMPACT PRODUCTS, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: B340791955M1
• NIH Device Record Key: 0606b60c-e11c-43c8-9d9f-0710f38f7bb2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 791955M
• Catalog Number: 791955
• 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	B340791955M1 [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: 2020-07-06
• Device Publish Date: 2020-06-26

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