SafeTouch Sterile Latex Surgical Gloves, 8 1/2

GUDID 00616784238517

Sterile-EO, Powder-Free / Cuffed

Dynarex Corporation

Hevea-latex surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 00616784238517
• NIH Device Record Key: 70d3996e-a4da-471a-a008-c28ed88a7441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeTouch Sterile Latex Surgical Gloves, 8 1/2
• Version Model Number: 2385
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784238517 [Primary]
GS1	00616784238524 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	00616784238531 [Package]; Contains: 00616784238524; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000896

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-23
• Device Publish Date: 2025-09-15

Devices Manufactured by Dynarex Corporation

• 00616784236018 - SafeTouch Sterile Latex Surgical Gloves, 6.0: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
• 00616784236513 - SafeTouch Sterile Latex Surgical Gloves, 6 1/2: 2025-09-23 Sterile-EO, Powdered-Free / Cuffed
• 00616784237015 - SafeTouch Sterile Latex Surgical Gloves, 7.0: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
• 00616784237510 - SafeTouch Sterile Latex Surgical Gloves, 7 1/2: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
• 00616784238012 - SafeTouch Sterile Latex Surgical Gloves, 8.0: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
• 00616784238517 - SafeTouch Sterile Latex Surgical Gloves, 8 1/2: 2025-09-23Sterile-EO, Powder-Free / Cuffed
• 00616784238517 - SafeTouch Sterile Latex Surgical Gloves, 8 1/2: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
• 00616784239019 - SafeTouch Sterile Latex Surgical Gloves, 9.0: 2025-09-23 Sterile-EO, Powder-Free / Cuffed
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