NITRILECARE PREMIUM

GUDID 09551006060839

Powder Free Nitrile Examination Gloves, Blue Chemotest - XXL gloves

CAREGLOVE GLOBAL SDN. BHD.

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

• Primary Device ID: 09551006060839
• NIH Device Record Key: aed2883e-ca4b-453b-9902-41fe1a6cd557
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITRILECARE PREMIUM
• Version Model Number: Nitrile XXL gloves
• Company DUNS: 865779649
• Company Name: CAREGLOVE GLOBAL 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551006060822 [Primary]
GS1	09551006060839 [Package]; Contains: 09551006060822; Package: Carton [10 Units]; In Commercial Distribution
GS1	09551006061492 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211666

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [NITRILECARE PREMIUM ]

• 09551006060839: Powder Free Nitrile Examination Gloves, Blue Chemotest - XXL gloves
• 09551006060617: Powder Free Nitrile Examination Gloves, Blue Chemotest - XL gloves
• 09551006060600: Powder Free Nitrile Examination Gloves, Blue Chemotest – L Gloves
• 09551006060594: Powder Free Nitrile Examination Gloves, Blue Chemotest – M Gloves
• 09551006060587: Powder Free Nitrile Examination Gloves, Blue Chemotest - S gloves
• 09551006060570: Powder Free Nitrile Examination Gloves, Blue Chemotest - XS gloves