Protect U Guard Nitro-Lion Nitrile Patient Examina

GUDID B086101041

Nitrile Patient Examination Glove, Indigo, Extra Large

PROTECT U GUARD, LLC

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

• Primary Device ID: B086101041
• NIH Device Record Key: 093e30b1-b6d9-42b0-8d5b-1b2e192da84a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protect U Guard Nitro-Lion Nitrile Patient Examina
• Version Model Number: P10104
• Company DUNS: 080070945
• Company Name: PROTECT U GUARD, LLC
• Device Count: 200
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B086101040 [Unit of Use]
HIBCC	B086101041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170397

FDA Product Code

• LZC: Patient Examination Glove, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-02

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• B086201042: Nitrile Patient Examination Glove, Indigo, Extra Large
• B086201032: Nitrile Patient Examination Glove, Indigo, Large
• B086201022: Nitrile Patient Examination Glove, Indigo, Medium
• B086201012: Nitrile Patient Examination Glove, Indigo, Small
• B086101141: Nitrile Patient Examination Glove, White, Extra Large
• B086101131: Nitrile Patient Examination Glove, White, Large
• B086101121: Nitrile Patient Examination Glove, White, Medium
• B086101111: Nitrile Patient Examination Glove, White, Small
• B086101041: Nitrile Patient Examination Glove, Indigo, Extra Large
• B086101031: Nitrile Patient Examination Glove, Indigo, Large
• B086101021: Patient Examination Glove, Indigo, Medium
• B086101011: Nitrile Patient Examination Glove, Indigo, Small