SafeTouch Sterile Latex Surgical Gloves, 9.0

GUDID 00616784239019

Sterile-EO, Powder-Free / Cuffed

Dynarex Corporation

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

• Primary Device ID: 00616784239019
• NIH Device Record Key: 7dd79ee7-53b5-40ea-8572-6c963d0ee9ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeTouch Sterile Latex Surgical Gloves, 9.0
• Version Model Number: 2390
• 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	00616784239019 [Primary]
GS1	00616784239026 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	00616784239033 [Package]; Contains: 00616784239026; 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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• 00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use: 2026-01-29
• 00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13
• 00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13
• 00840117344136 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm): 2026-01-13 STERILE-EO, CONTENT: 1. Catheter, 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22 mm Flex Tube, 1. 15 mm x 22 mm Adaptor, 1. Tra