Safe-Touch Black Nitrile Examination Gloves, Powder-Free, XX-Large

GUDID 00616784252513

Ambidextrous / Textured fingers

DYNAREX CORPORATION

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

• Primary Device ID: 00616784252513
• NIH Device Record Key: 1d819863-7454-44b5-97a3-9774dfe74a03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safe-Touch Black Nitrile Examination Gloves, Powder-Free, XX-Large
• Version Model Number: 2525
• 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	00616784252513 [Unit of Use]
GS1	00616784252520 [Primary]
GS1	00616784252537 [Package]; Contains: 00616784252520; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

FDA Product Code

• LZA: Polymer Patient Examination Glove
• LZC: Medical Glove, Specialty

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: 2023-05-02
• Device Publish Date: 2023-04-24

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