NitriDerm® COATS™

GUDID 00813172020628

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

INNOVATIVE HEALTHCARE CORPORATION

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

• Primary Device ID: 00813172020628
• NIH Device Record Key: 3e15e6da-8c1b-4d45-ab28-1582cc8f623d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NitriDerm® COATS™
• Version Model Number: 125052
• Company DUNS: 802020693
• Company Name: INNOVATIVE HEALTHCARE CORPORATION
• 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: 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	00813172020628 [Unit of Use]
GS1	10813172020625 [Package]; Contains: 20813172020622; Package: 200/bx, 10 bx/cs [10 Units]; In Commercial Distribution
GS1	20813172020622 [Primary]

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-03
• Device Publish Date: 2022-12-08

Devices Manufactured by INNOVATIVE HEALTHCARE CORPORATION

• 00813172022356 - Prestige® Orthopaedic: 2025-02-26 Gloves, Surgical, Latex, Powder-Free, Textured, Bisque Finish, 6.5
• 00813172021922 - BLACK WOLF™: 2025-02-26 Gloves, Exam, Latex, Non-Sterile, Powder-Free, Textured, Black, M
• 20813172021308 - NitriDerm® EC Pairs: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, M
• 20813172021315 - NitriDerm® EC Pairs: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, L
• 20813172021322 - NitriDerm® EC Pairs: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, XL
• 00813172023896 - NitriDerm® 800: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, USP 797/800, M
• 20813172023906 - NitriDerm® 800: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, USP 797/800, L
• 20813172023913 - NitriDerm® 800: 2025-02-24 Gloves, Exam, Nitrile, Sterile, Chemo, Powder-Free, Pairs, Extended Cuff, USP 797/800, XL