MocareHealth

GUDID 16971384153754

Sterile Polyisoprene Powder-Free Surgical Gloves - Blue

Motex Healthcare(Anhui)Co.,Ltd.

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

• Primary Device ID: 16971384153754
• NIH Device Record Key: b3a180e5-d8b7-4ff2-8729-99aecbe193cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MocareHealth
• Version Model Number: 7529F/5.5
• 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	16971384153754 [Primary]

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

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

[16971384153754]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-16

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• 36971384150924: Single-use sterile rubber surgical gloves
• 36971384150917: Single-use sterile rubber surgical gloves
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• 36971384150894: Single-use sterile rubber surgical gloves
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