GENERIC

GUDID 00860002339603

UNITED MEDICAL INC

Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00860002339603
• NIH Device Record Key: e90417f5-5b13-49c4-a71a-151a024b8d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENERIC
• Version Model Number: VY001XS
• Company DUNS: 081105003
• Company Name: UNITED MEDICAL 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002339603 [Primary]
GS1	00860002339610 [Unit of Use]
GS1	00860002339627 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173561

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: 2019-08-28
• Device Publish Date: 2019-08-20