Nulife ELGLUE

GUDID 08905159002146

Elbow Length gynaecology gloves are sterile and anatomically shaped medical gloves with the thumb positioned towards the palmer surface of the index finger rather than lying flat with length till elbow. These gloves are powder-free. The Elbow length gynaecology gloves are intended for use various gynecological procedures.

MRK HEALTHCARE PRIVATE LIMITED

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

• Primary Device ID: 08905159002146
• NIH Device Record Key: 6682b72c-a41b-4c06-84b1-dc6116e0531d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nulife
• Version Model Number: Elbow length Gynaecology gloves - 8.5
• Catalog Number: ELGLUE
• Company DUNS: 650986016
• Company Name: MRK HEALTHCARE PRIVATE 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com
• Phone: +912262611111
• Email: regulatory@mrkhealthcare.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08905159002146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210969

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-06-28

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