ORCARE SURGICAL LATEX PF

GUDID 09551006060518

Sterile Latex Surgical Gloves, Powder Free

CAREGLOVE GLOBAL SDN. BHD.

Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial Hevea-latex examination/treatment glove, non-powdered, antimicrobial

• Primary Device ID: 09551006060518
• NIH Device Record Key: 02ffe927-ccd4-4ae7-99bb-5430a9a86d44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORCARE SURGICAL LATEX PF
• Version Model Number: 8.5
• Company DUNS: 865779649
• Company Name: CAREGLOVE GLOBAL SDN. BHD.
• Device Count: 50
• 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
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com
• Phone: +6067292130
• Email: farhana.aqilah@careplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09551006060464 [Primary]
GS1	09551006060518 [Package]; Contains: 09551006060464; Package: Carton [4 Units]; In Commercial Distribution
GS1	09551006061478 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190241

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-08
• Device Publish Date: 2023-12-29

On-Brand Devices [ORCARE SURGICAL LATEX PF]

• 09551006061058: Sterile Latex Surgical Gloves, Powder Free
• 09551006061041: Sterile Latex Surgical Gloves, Powder Free
• 09551006061034: Sterile Latex Surgical Gloves, Powder Free
• 09551006060518: Sterile Latex Surgical Gloves, Powder Free
• 09551006060501: Sterile Latex Surgical Gloves, Powder Free
• 09551006060495: Sterile Latex Surgical Gloves, Powder Free
• 09551006060488: Sterile Latex Surgical Gloves, Powder Free
• 09551006060471: Sterile Latex Surgical Gloves, Powder Free