Next Generation Stretch Vinyl Exam Gloves

GUDID 00709553682533

Next Generation Stretch Vinyl Exam Gloves, Powder-Free, X-Large

DYNAREX CORPORATION

Ethylene vinyl acetate examination/treatment glove, non-powdered, non-sterile

• Primary Device ID: 00709553682533
• NIH Device Record Key: 68fd04f6-55f9-42c6-a602-532722495eaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Next Generation Stretch Vinyl Exam Gloves
• Version Model Number: 6825
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709553682519 [Unit of Use]
GS1	00709553682526 [Primary]
GS1	00709553682533 [Package]; Contains: 00709553682526; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100486

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: 2021-05-31
• Device Publish Date: 2021-05-21

On-Brand Devices [Next Generation Stretch Vinyl Exam Gloves]

• 00709553682533: Next Generation Stretch Vinyl Exam Gloves, Powder-Free, X-Large
• 00709553682434: Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Large
• 00709553682335: Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Medium
• 00709553682236: Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Small