NitriDerm® Ultra Pro™

GUDID 10813172020328

Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Cobalt Blue, 5.1 mil, XXL

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 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: 10813172020328
• NIH Device Record Key: cce5ae17-abd0-4843-a954-4e7d69a5f79c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NitriDerm® Ultra Pro™
• Version Model Number: 188400
• Company DUNS: 802020693
• Company Name: INNOVATIVE HEALTHCARE CORPORATION
• Device Count: 80
• 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	00813172020321 [Unit of Use]
GS1	10813172020328 [Package]; Contains: 20813172020325; Package: 80/bx, 10 bx/cs [10 Units]; In Commercial Distribution
GS1	20813172020325 [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: 2024-05-21
• Device Publish Date: 2022-12-08

Devices Manufactured by INNOVATIVE HEALTHCARE CORPORATION

• 10813172020892 - NitriDerm® EP Orange®: 2024-06-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Ext Cuff, Orange, 6.5 mil, S
• 20813172020547 - Pulse® Nitrile: 2024-05-23 Gloves, Exam, Nitrile, Non-Sterile, Powder-Free, Textured, Thinfilm, L
• 10813172020328 - NitriDerm® Ultra Pro™: 2024-05-21Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Cobalt Blue, 5.1 mil, XXL
• 10813172020328 - NitriDerm® Ultra Pro™: 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Cobalt Blue, 5.1 mil, XXL
• 10813172020502 - NitriDerm® Ultra Orange™: 2024-05-21 Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXL
• 10813172020519 - NitriDerm® Ultra Orange™: 2024-05-21 Gloves, Exam, Nitrile, Non-Sterile,Powder-Free, Textured, Orange, XXXL
• 10813172020939 - NitriDerm® EP Orange®: 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Ext Cuff, Orange, 6.5 mil, XXL
• 10813172020946 - NitriDerm® EP Orange®: 2024-05-21 Gloves, Exam, Nitrile, Chemo, Non-Sterile, Powder-Free, Textured, Ext Cuff, Orange, 6.5 mil, XXXL
• 00813172024619 - DermAssist®: 2023-09-11 Gloves, Exam, Vinyl, Non-Sterile, Powder-Free, Stretch, Blue, XL