NWCS Medical Divison ArmorGuard

GUDID 00860010386460

New Wave Cleaning Solutions LLC

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

• Primary Device ID: 00860010386460
• NIH Device Record Key: 28a0dbda-4444-457d-81d4-736d603730e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NWCS Medical Divison ArmorGuard
• Version Model Number: NG-BLUE-LG
• Company DUNS: 047495265
• Company Name: New Wave Cleaning Solutions LLC
• Device Count: 100
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010386415 [Primary]
GS1	00860010386460 [Package]; Contains: 00860010386415; Package: Case [10 Units]; In Commercial Distribution
GS1	10860010386412 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112294

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: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [NWCS Medical Divison ArmorGuard]

• 00860010386446: NG-BLUE-SM
• 00860010386453: NG-BLUE-MED
• 00860010386460: NG-BLUE-LG
• 00860010386477: NG_BLUE-XL