Safe-Touch Vinyl Examination Gloves, Powder-Free

GUDID 00616784252414

X-Large Ambidextrous Textured Fingers

DYNAREX CORPORATION

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

• Primary Device ID: 00616784252414
• NIH Device Record Key: 9e477d62-32e1-4869-a1df-518dfd994db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Touch Vinyl Examination Gloves, Powder-Free
• Version Model Number: 2524
• 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	00616784252414 [Unit of Use]
GS1	00616784252421 [Primary]
GS1	00616784252438 [Package]; Contains: 00616784252421; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2022-09-15
• Device Publish Date: 2022-09-07

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