MocareHealth

GUDID 36971384150931

Single-use sterile rubber surgical gloves

Motex Healthcare(Anhui)Co.,Ltd.

Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 36971384150931
• NIH Device Record Key: 4742de76-6b6c-4baa-ad99-a32044487d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MocareHealth
• Version Model Number: 1610/9.5
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	26971384150934 [Primary]
GS1	36971384150931 [Package]; Contains: 26971384150934; Package: CASE [6 Units]; Discontinued: 2026-08-26; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063757

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

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

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

[36971384150931]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-03
• Device Publish Date: 2021-08-26

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