NitriDerm® Soothe™

GUDID 20813172025344

Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, S

INNOVATIVE HEALTHCARE CORPORATION

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

• Primary Device ID: 20813172025344
• NIH Device Record Key: 06476032-78b3-426d-b623-d1ce14e20122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NitriDerm® Soothe™
• Version Model Number: 126100
• Company DUNS: 802020693
• Company Name: INNOVATIVE HEALTHCARE CORPORATION
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813172025340 [Unit of Use]
GS1	10813172025347 [Primary]
GS1	20813172025344 [Package]; Contains: 10813172025347; Package: 250/bx, 10 bx/cs [10 Units]; In Commercial Distribution

FDA Product Code

• LZA: Polymer 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: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [NitriDerm® Soothe™]

• 40813172025331: Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, XS
• 20813172025344: Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, S
• 20813172025375: Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, XL
• 20813172025368: Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, L
• 20813172025351: Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Colloidal Oatmeal, Therapeutic, M