ZIOXX Natural Rubber Latex Male Condom

GUDID 06977708230043

Shaoguan Regenex Pharmaceutical Co., Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 06977708230043
• NIH Device Record Key: ad64c925-ec72-4e0e-9033-ab5b2625a9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIOXX Natural Rubber Latex Male Condom
• Version Model Number: 55mm Reservoir tip
• Company DUNS: 710872591
• Company Name: Shaoguan Regenex Pharmaceutical Co., Ltd.
• 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: true
• Manufacturing Date: true
• 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	06977708230043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250034

FDA Product Code

• HIS: Condom

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: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [ZIOXX Natural Rubber Latex Male Condom]

• 06977708230043: 55mm Reservoir tip
• 06977708230036: 55mm Non-Reservoir tip
• 06977708230029: 52mm Reservoir tip
• 06977708230012: 52mm Non-Reservoir tip