Flextreme

GUDID 10850018123683

5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder Free, Textured Finger Tips, Steel Blue, Size 3X-Large

P H & S PRODUCTS LLC

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

• Primary Device ID: 10850018123683
• NIH Device Record Key: 715a6c5a-616f-416d-8fe0-4cd72a1d1c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flextreme
• Version Model Number: 1LFTNG-3XL
• Company DUNS: 968344643
• Company Name: P H & S PRODUCTS LLC
• Device Count: 100
• 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: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com
• Phone: +1(330)868-2239
• Email: klynn@phs-products.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018123686 [Primary]
GS1	00850018123839 [Unit of Use]
GS1	10850018123683 [Package]; Contains: 00850018123686; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990878

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: 2020-08-10
• Device Publish Date: 2020-08-01

On-Brand Devices [Flextreme]

• 10850018123683: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F
• 10850018123669: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F
• 10850018123645: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F
• 10850018123621: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F
• 10850018123607: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F
• 10850018123584: 5mil Fingertip, 12" in Length, Nitrile, NFPA Approved, Accelerator, Sulfur & Zinc Free, Powder F