Vinyl Gloves

GUDID 00616784261614

Vinyl Gloves, Power-Free, 1 pair per bag, Large

DYNAREX CORPORATION

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00616784261614
• NIH Device Record Key: eaaf312e-0f62-46b3-a600-3daccbd4d133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vinyl Gloves
• Version Model Number: 2616
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• 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	00616784261614 [Primary]
GS1	00616784261638 [Package]; Package: Case [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131832

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: 2022-04-22

On-Brand Devices [Vinyl Gloves]

• 00616784261706: Vinyl Gloves, Power-Free, 2 Pairs per bag, Large
• 00616784261614: Vinyl Gloves, Power-Free, 1 pair per bag, Large