STEELFLEX ANST353

GUDID 00850040723281

STEELFLEX SIZE M, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glove

American Nitrile Operations, 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

• Primary Device ID: 00850040723281
• NIH Device Record Key: 07ccf014-b0c4-4730-842d-8aff39075332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEELFLEX
• Version Model Number: ANST353
• Catalog Number: ANST353
• Company DUNS: 118378851
• Company Name: American Nitrile Operations, LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx
• Phone: 614-600-2655
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850040723137 [Primary]
GS1	00850040723281 [Package]; Contains: 00850040723137; Package: Case of 2000 [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220825

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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [STEELFLEX]

• 00850040723298: STEELFLEX SIZE L, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glo
• 00850040723281: STEELFLEX SIZE M, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glo
• 00850040723274: STEELFLEX SIZE S, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Glo
• 00850040723304: STEELFLEX SIZE XL, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Gl
• 00850040723113: STEELFLEX SIZE XS, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination Gl
• 00850040723250: STEELFLEX SIZE XXL, Blue Nitrile Powder-Free, Chemo and Fentanyl Resistant Patient Examination G