Protect U Guard Nitro-Lion LD Nitrile Patient Exam P10121

GUDID B086201212

Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powder Free, Low Dermatitis Potential Box of 250 Gloves

PROTECT U GUARD, LLC

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

• Primary Device ID: B086201212
• NIH Device Record Key: 105400b1-05b7-4e72-9793-ca4203926086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protect U Guard Nitro-Lion LD Nitrile Patient Exam
• Version Model Number: P10121
• Catalog Number: P10121
• Company DUNS: 080070945
• Company Name: PROTECT U GUARD, LLC
• Device Count: 250
• 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	B086101210 [Unit of Use]
HIBCC	B086101211 [Primary]
HIBCC	B086201212 [Package]; Contains: B086101211; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151824

FDA Product Code

• LZC: Patient Examination Glove, Specialty

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: 2018-09-27
• Device Publish Date: 2018-08-27

On-Brand Devices [Protect U Guard Nitro-Lion LD Nitrile Patient Exam]

• B086201242: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
• B086201232: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
• B086201222: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
• B086201212: Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde