MocareHealth

GUDID 36971384150030

Single-Use Nitrile Examination Gloves

Motex Healthcare(Anhui)Co.,Ltd.

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: 36971384150030
• NIH Device Record Key: b9a2e2ab-bcdd-482a-9e23-982daa92b867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MocareHealth
• Version Model Number: 7235M
• Company DUNS: 560080502
• Company Name: Motex Healthcare(Anhui)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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	26971384150033 [Primary]
GS1	36971384150030 [Package]; Contains: 26971384150033; Package: CASE [10 Units]; Discontinued: 2021-08-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030207

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: 2021-09-01
• Device Publish Date: 2021-08-24

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