ZHONGHONG PULIN

GUDID 06970405800045

Zhonghong Pulin Medical Products Co.,Ltd.

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

• Primary Device ID: 06970405800045
• NIH Device Record Key: b888bd52-805e-48bc-af97-68495fa56b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZHONGHONG PULIN
• Version Model Number: S
• Company DUNS: 548208657
• Company Name: Zhonghong Pulin Medical Products 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: false
• 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	06970405800045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082598

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: 2021-01-14
• Device Publish Date: 2021-01-06

On-Brand Devices [ZHONGHONG PULIN]

• 06970405800212: S
• 06970405800045: S