DermaThin M7002PFXL

GUDID 10038054654303

SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim, fingertip textured, Blue, XL

SHOWA BEST GLOVE, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 10038054654303
• NIH Device Record Key: a69c70e6-7881-4bcb-920c-82f611baea8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaThin
• Version Model Number: XL
• Catalog Number: M7002PFXL
• Company DUNS: 807930412
• Company Name: SHOWA BEST GLOVE, INC.
• Device Count: 180
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com
• Phone: 800-241-0323
• Email: USA@Showagroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00038054654306 [Primary]
GS1	10038054654303 [Package]; Contains: 00038054654306; Package: [10 Units]; In Commercial Distribution
GS1	20038054654300 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211003

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: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [DermaThin]

• 10038054654396: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,
• 10038054654389: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,
• 10038054654372: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,
• 00038054654368: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,
• 10038054654310: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,
• 10038054654303: SHOWA, DermaThin® Nitrile PF Exam Biodegradable with Eco Best Technology® (EBT), Chemo claim,