SafeTouch Sterile Latex Surgical Gloves, 7 1/2

GUDID 00616784237510

Sterile-EO, Powder-Free / Cuffed

Dynarex Corporation

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

• Primary Device ID: 00616784237510
• NIH Device Record Key: 0f457157-d9e8-4004-9fc6-1db96e334d6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeTouch Sterile Latex Surgical Gloves, 7 1/2
• Version Model Number: 2375
• 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	00616784237510 [Primary]
GS1	00616784237527 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	00616784237534 [Package]; Contains: 00616784237527; 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

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