NITRILECARE BLUE PF

GUDID 09551006060044

Powder Free Nitrile Examination Gloves, Blue (colored) - XL gloves

CAREGLOVE GLOBAL SDN. BHD.

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 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: 09551006060044
• NIH Device Record Key: 8d8ed3e4-ad95-45f2-ae6a-388e75df4bae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITRILECARE BLUE PF
• Version Model Number: Nitrile XL 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: true
• Labeled No Natural Rubber Latex: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551006060044 [Package]; Contains: 09551006060105; Package: Carton [10 Units]; In Commercial Distribution
GS1	09551006060105 [Primary]
GS1	09551006061485 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172015

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: 2023-12-04
• Device Publish Date: 2023-11-24

On-Brand Devices [NITRILECARE BLUE PF ]

• 09551006060051: Powder Free Nitrile Examination Gloves, Blue (colored) - XXL gloves
• 09551006060044: Powder Free Nitrile Examination Gloves, Blue (colored) - XL gloves
• 09551006060037: Powder Free Nitrile Examination Gloves, Blue (Colored) – L Gloves
• 09551006060020: Powder Free Nitrile Examination Gloves, Blue (Colored) – M Gloves
• 09551006060013: Powder Free Nitrile Examination Gloves, Blue (colored) - S gloves
• 09551006060006: Powder Free Nitrile Examination Gloves, Blue (colored) - XS gloves