BYD CARE

GUDID 16974528640042

Sizs S

BYD Auto Industry Company Limited

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 16974528640042
• NIH Device Record Key: 58c24e6a-ae2b-4358-b999-ed9f335aa1a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BYD CARE
• Version Model Number: NE01
• Company DUNS: 545351723
• Company Name: BYD Auto Industry Company Limited
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974528640045 [Primary]
GS1	16974528640042 [Package]; Contains: 06974528640045; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212840

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: 2022-01-06
• Device Publish Date: 2021-12-29

On-Brand Devices [BYD CARE]

• 16974528640073: Size XL
• 16974528640066: Size L
• 16974528640059: Size M
• 16974528640042: Sizs S