Glyde QA-224

GUDID 09556807500898

Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested

RICHTER RUBBER TECHNOLOGY SDN. BHD.

Basic male condom, Hevea-latex

• Primary Device ID: 09556807500898
• NIH Device Record Key: caefe83b-f118-4af3-b3bf-a64bef594a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glyde
• Version Model Number: Pro Ultra
• Catalog Number: QA-224
• Company DUNS: 652647942
• Company Name: RICHTER RUBBER TECHNOLOGY SDN. BHD.
• Device Count: 100
• DM Exempt: true
• 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: 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: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09556807500898 [Unit of Use]
GS1	19556807570881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070511

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: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [Glyde]

• 09556807500898: Natural latex male condom. Transparent, cylindrical shaped, nominal width 53 mm, smooth with res
• 09556807500874: Natural latex male condom. Transparent, cylindrical shaped, nominal width 49 mm, smooth with res
• 09556807500850: Natural latex male condom. Transparent, plain, nominal width 57 mm, smooth with reservoir. Lubri