Decontam Exam Gloves TDG-2-50

GUDID 10848956007332

M DECONTAM EXAM GLOVE - 14MIL

HEALTHMARK INDUSTRIES CO., INC.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 10848956007332
• NIH Device Record Key: 035f6521-eae0-4584-abc2-853f741aaa37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Decontam Exam Gloves
• Version Model Number: TDG-2-50
• Catalog Number: TDG-2-50
• Company DUNS: 057680480
• Company Name: HEALTHMARK INDUSTRIES CO., INC.
• Device Count: 50
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848956007335 [Unit of Use]
GS1	10848956007332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221157

FDA Product Code

• LZC: Medical Glove, Specialty

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: 2025-01-08
• Device Publish Date: 2024-12-31

On-Brand Devices [Decontam Exam Gloves]

• 20848956007353: TDG-4-500
• 20848956007346: TDG-3-500
• 20848956007339: TDG-2-500
• 20848956007322: S DECONTAM EXAM GLOVE - 14MIL
• 10848956007356: TDG-4-50
• 10848956007349: TDG-3-50
• 10848956007332: M DECONTAM EXAM GLOVE - 14MIL
• 10848956007325: S DECONTAM EXAM GLOVE - 14MIL