ESTEEM 8899EC

GUDID 50885380174306

Nitrile Exam Gloves

Cardinal Health 200, LLC

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

• Primary Device ID: 50885380174306
• NIH Device Record Key: ed2e8fce-ad33-4e97-a5a3-367e8853f11c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESTEEM
• Version Model Number: 8899EC
• Catalog Number: 8899EC
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, 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: false
• Expiration Date: true
• 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	10885380174308 [Unit of Use]
GS1	20885380174305 [Primary]
GS1	50885380174306 [Package]; Contains: 20885380174305; Package: EACH [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183354

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: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [ESTEEM]

• 50885380135086: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380163966: Nitrile Exam Gloves ESTEEM Comfort
• 50885380163959: Nitrile Exam Gloves ESTEEM Comfort
• 50885380163942: Nitrile Exam Gloves ESTEEM Comfort
• 50885380163935: Nitrile Exam Gloves ESTEEM Comfort
• 50885380163928: Nitrile Exam Gloves ESTEEM Comfort
• 50885380163911: Nitrile Exam Gloves ESTEEM Comfort
• 50885380137165: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380135529: Vinyl Exam Gloves
• 50885380135512: Vinyl Exam Gloves
• 50885380135505: Vinyl Exam Gloves
• 50885380135499: Vinyl Exam Gloves
• 50885380135482: Vinyl Exam Gloves
• 50885380135437: Esteem Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moist
• 50885380135420: Esteem Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moist
• 50885380135413: Esteem Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moist
• 50885380135406: Esteem Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moist
• 50885380135390: Esteem Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moist
• 50885380135383: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135376: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135369: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135352: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135345: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135338: Esteem with Neu-Thera Powder-Free Nitrile Exam Gloves
• 50885380135154: Nitrile Exam Gloves
• 50885380135147: Nitrile Exam Gloves
• 50885380135123: Nitrile Exam Gloves
• 50885380135116: Nitrile Exam Gloves
• 50885380135109: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380135093: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380135079: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380135062: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380134874: Micro Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380134867: Micro Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380134850: Micro Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380134843: Micro Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
• 50885380134836: NITRILE EXAM GLOVES ESTEEM STRETCHY NITRILE Fully Textured Chemotherapy Drug Tested
• 50885380134829: NITRILE EXAM GLOVES ESTEEM STRETCHY NITRILE Fully Textured Chemotherapy Drug Tested
• 50885380041981: Nitrile Exam Gloves
• 50885380041950: Nitrile Exam Gloves
• 50885380166196: Nitrile Exam Gloves
• 50885380174306: Nitrile Exam Gloves
• 50885380174290: Nitrile Exam Gloves
• 50885380174283: Nitrile Exam Gloves
• 50885380174276: Nitrile Exam Gloves
• 20885380176927: Nitrile Exam Gloves
• 20885380176910: Nitrile Exam Gloves
• 50885380176904: Nitrile Exam Gloves
• 50885380176898: Nitrile Exam Gloves
• 50885380135161: Nitrile Exam Gloves Esteem Stretch