ECO

GUDID 19551012410038

ECO MEDI GLOVE SDN. BHD.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 19551012410038
• NIH Device Record Key: c7226e23-f299-4e3a-aa2d-023e2514fec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO
• Version Model Number: EMNE80253
• Company DUNS: 813056487
• Company Name: ECO MEDI GLOVE SDN. BHD.
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551012410031 [Primary]
GS1	19551012410038 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141590

FDA Product Code

• LZA: Polymer Patient Examination Glove

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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [ECO ]

• 19551012410045: EMNE80254
• 19551012410038: EMNE80253
• 19551012410021: EMNE80252
• 19551012410014: EMNE80251
• 19551012410007: EMNE80250