DHG DNGB-XL

GUDID 00810998039322

DHG brand nitrile gloves size XL color black powder-free, 10/100, 3.5 mil, exam grade

Winsight International Solutions, Inc.

Surgical/examination garment kit

• Primary Device ID: 00810998039322
• NIH Device Record Key: 1ef12dfe-79ab-45ca-ba86-80c158b48e69
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DHG
• Version Model Number: DNGB-XL
• Catalog Number: DNGB-XL
• Company DUNS: 079694430
• Company Name: Winsight International Solutions, Inc.
• Device Count: 1000
• 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	00810998039315 [Primary]
GS1	00810998039322 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141303

FDA Product Code

• NJG: Flasher, Afterimage, Ophthalmic

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: 2022-09-06
• Device Publish Date: 2022-08-29

On-Brand Devices [DHG]

• 00810998039322: DHG brand nitrile gloves size XL color black powder-free, 10/100, 3.5 mil, exam grade
• 00810998039308: DHG brand nitrile gloves size L color black powder-free, 10/100, 3.5 mil, exam grade
• 00810998039285: DHG brand nitrile gloves size M color black powder-free, 10/100, 3.5 mil, exam grade