CHLOROPRENE EXAMINATION PF

GUDID 09551006061331

Chloroprene Examination Gloves Powder Free (Blue, Green) - 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 Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 09551006061331
• NIH Device Record Key: 4255ea1c-35c1-478e-b0fd-7b364c8f0757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHLOROPRENE EXAMINATION PF
• Version Model Number: Chloroprene 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: 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	09551006061287 [Primary]
GS1	09551006061331 [Package]; Contains: 09551006061287; Package: Carton [10 Units]; In Commercial Distribution
GS1	09551006061515 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213993

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 [CHLOROPRENE EXAMINATION PF ]

• 09551006061331: Chloroprene Examination Gloves Powder Free (Blue, Green) - XL gloves
• 09551006061324: Chloroprene Examination Gloves Powder Free (Blue, Green) – L Gloves
• 09551006061317: Chloroprene Examination Gloves Powder Free (Blue, Green) – M Gloves
• 09551006061300: Chloroprene Examination Gloves Powder Free (Blue, Green) - S gloves
• 09551006061294: Chloroprene Examination Gloves Powder Free (Blue, Green)- XS gloves