Safe-Touch Black Nitrile Examination Gloves, Powder-Free

GUDID 00616784252117

Small Ambidextrous Textured Fingers

DYNAREX CORPORATION

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

• Primary Device ID: 00616784252117
• NIH Device Record Key: ef2414f0-9e42-46d1-9d3a-a0f82e362883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Touch Black Nitrile Examination Gloves, Powder-Free
• Version Model Number: 2521
• 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	00616784252117 [Unit of Use]
GS1	00616784252124 [Primary]
GS1	00616784252131 [Package]; Contains: 00616784252124; 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: 2022-09-14
• Device Publish Date: 2022-09-06

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

• 00616784252216: Medium Ambidextrous Textured Fingers
• 00616784252117: Small Ambidextrous Textured Fingers
• 00616784252315: Large Ambidextrous Textured Fingers