Amerglo TPF LEGPFT

GUDID 09551023920123

Powder Free Latex Examination Gloves Size: M

MARCON RUBBER INDUSTRY SDN BHD

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

• Primary Device ID: 09551023920123
• NIH Device Record Key: 69e797dc-084e-47eb-ae35-212acf721fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amerglo TPF
• Version Model Number: LEGPFT M
• Catalog Number: LEGPFT
• Company DUNS: 652593823
• Company Name: MARCON RUBBER INDUSTRY SDN BHD
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551023920123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973615

FDA Product Code

• LYY: Latex 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: 2024-04-01
• Device Publish Date: 2024-03-22

On-Brand Devices [Amerglo TPF]

• 09551023920147: Powder Free Latex Examination Gloves Size: XL
• 09551023920130: Powder Free Latex Examination Gloves Size: L
• 09551023920123: Powder Free Latex Examination Gloves Size: M
• 09551023920116: Powder Free Latex Examination Gloves Size: S
• 09551023920109: Powder Free Latex Examination Gloves Size: XS