MedPride MPR-51615

GUDID 00352410516153

Intended to be used in surgery for patients and user

SHIELD-LINE, LLC

Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered

• Primary Device ID: 00352410516153
• NIH Device Record Key: 010009f1-6f82-433b-8379-81124ed13ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedPride
• Version Model Number: SIZE 7.5
• Catalog Number: MPR-51615
• Company DUNS: 078518916
• Company Name: SHIELD-LINE, LLC
• Device Count: 50
• 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: true
• 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	00352410516153 [Unit of Use]
GS1	10352410516150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122557

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-15
• Device Publish Date: 2021-10-07

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• 00352410516177: Intended to be used in surgery for patients and user
• 00352410516160: Intended to be used in surgery for patients and user
• 00352410516153: Intended to be used in surgery for patients and user
• 00352410516146: Intended to be used in surgery for patients and user
• 00352410516139: Intended to be used in surgery for patients and user
• 00352410516122: Intended to be used in surgery for patients and user