CAP'N K

GUDID 00810169800904

PRIME SOLUTIONS, INC.

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

• Primary Device ID: 00810169800904
• NIH Device Record Key: 35023395-c339-45dd-b6ef-b31a8d8c82cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAP'N K
• Version Model Number: MWSPN/2XL
• 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: true
• 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	00810169800850 [Primary]
GS1	00810169800904 [Package]; Contains: 00810169800850; Package: CASE [10 Units]; In Commercial Distribution
GS1	10810169800857 [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: 2025-06-23
• Device Publish Date: 2025-06-14