nitrylex classic+

GUDID 18859185201301

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack 10 inner boxes/1 carton

MERCATOR MEDICAL (THAILAND) LIMITED

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

• Primary Device ID: 18859185201301
• NIH Device Record Key: 243639d2-1a9d-40b1-a680-0600a19f1578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nitrylex classic+
• Version Model Number: RD30246904_0001
• Company DUNS: 671647476
• Company Name: MERCATOR MEDICAL (THAILAND) LIMITED
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	18859185201301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172930

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: 2021-03-15
• Device Publish Date: 2021-03-05

On-Brand Devices [nitrylex classic+]

• 18859185201318: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack 10 inner bo
• 18859185201301: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack 10 inner box
• 18859185201295: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: M Pack 10 inner boxe
• 18859185201288: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: S Pack 10 inner box
• 18859185201271: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XS Pack 10 inner box
• 08859185201311: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack 100 pieces/
• 08859185201304: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack 100 pieces/i
• 08859185201298: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: M Pack 100 pieces/i
• 08859185201281: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: S Pack 100 pieces/i
• 08859185201274: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XS Pack 100 pieces/