Gymda

GUDID 06974538550112

Medical Examination Gloves

Guangdong Gymda Medical Technology 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

• Primary Device ID: 06974538550112
• NIH Device Record Key: 778403ac-7451-40d2-b896-b10dc2ec9d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gymda
• Version Model Number: M
• Company DUNS: 602908023
• Company Name: Guangdong Gymda Medical Technology 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974538550112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212078

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: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [Gymda]

• 06974538550174: Medical Examination Gloves(Tested for use with Chemotherapy Drugs)
• 06974538550167: Medical Examination Gloves(Tested for use with Chemotherapy Drugs)
• 06974538550150: Medical Examination Gloves(Tested for use with Chemotherapy Drugs)
• 06974538550143: Medical Examination Gloves(Tested for use with Chemotherapy Drugs)
• 06974538550136: Medical Examination Gloves
• 06974538550129: Medical Examination Gloves
• 06974538550112: Medical Examination Gloves
• 06974538550105: Medical Examination Gloves