NITRILECARE ELITE

GUDID 09551006060693

Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)– M 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 Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 09551006060693
• NIH Device Record Key: 7c85b219-7c0f-4e0b-af34-b452a1933d67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NITRILECARE ELITE
• Version Model Number: M 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	09551006060648 [Primary]
GS1	09551006060693 [Package]; Contains: 09551006060648; Package: Carton [10 Units]; In Commercial Distribution
GS1	09551006061508 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230121

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 ELITE]

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• 09551006060716: Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate
• 09551006060709: Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate
• 09551006060693: Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate
• 09551006060686: Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate
• 09551006060679: Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs & Fentanyl Citrate