DERMATOUCH

GUDID 00810169800546

PRIME SOLUTIONS, INC.

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

• Primary Device ID: 00810169800546
• NIH Device Record Key: 96b80e49-1871-462b-8f21-423f86a292ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMATOUCH
• Version Model Number: 81135/S
• Company DUNS: 093300590
• Company Name: PRIME SOLUTIONS, INC.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810169800485 [Primary]
GS1	00810169800546 [Package]; Contains: 00810169800485; Package: CASE [10 Units]; In Commercial Distribution
GS1	10810169800482 [Unit of Use]

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: 2025-07-21
• Device Publish Date: 2025-07-11

On-Brand Devices [DERMATOUCH]

• 00810169800751: 81250MD/2XL
• 00810169800744: 81250MD/XL
• 00810169800737: 81250MD/L
• 00810169800720: 81250MD/M
• 00810169800713: 81250MD/S
• 00810169800584: 81135/2XL
• 00810169800577: 81135/XL
• 00810169800560: 81135/L
• 00810169800553: 81135/M
• 00810169800546: 81135/S
• 00810169800539: 81135/XS