Safe-Touch Vinyl Examination Gloves, Powder-Free

GUDID 00616784261317

Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Large

DYNAREX CORPORATION

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00616784261317
• NIH Device Record Key: bdb125f1-a737-4614-a4d6-6a7ada08c0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Touch Vinyl Examination Gloves, Powder-Free
• Version Model Number: 2613
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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	00616784261317 [Unit of Use]
GS1	00616784261324 [Primary]
GS1	00616784261331 [Package]; Contains: 00616784261324; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100339

FDA Product Code

• LYZ: Vinyl 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: 2022-05-02
• Device Publish Date: 2022-04-23

On-Brand Devices [Safe-Touch Vinyl Examination Gloves, Powder-Free]

• 00616784261416: Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, X-Large
• 00616784261317: Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Large
• 00616784261218: Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Medium
• 00616784261119: Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Small
• 00616784252414: X-Large Ambidextrous Textured Fingers