HENCHAN

GUDID 06949809200010

VINYL GLOVES, POWDER FREE, NON STERILE

Shandong Hengchang Medical Technology Co.,Ltd

Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 06949809200010
• NIH Device Record Key: d6c84569-fabf-473e-879d-c588fe2f144b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HENCHAN
• Version Model Number: HCMUXXX
• Company DUNS: 544076970
• Company Name: Shandong Hengchang Medical Technology Co.,Ltd
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06949809200010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042952

FDA Product Code

• LYZ: Vinyl 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: 2021-07-13
• Device Publish Date: 2021-07-05