Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested For Use With The Opioids Fentanyl Citrate, Heroin, And Both Opioids In Simulated Gastric Acid (Vomit)

Polymer Patient Examination Glove

Summit Glove, Inc

The following data is part of a premarket notification filed by Summit Glove, Inc with the FDA for Nitrile Two Toned Blue/green, Powder-free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested For Use With The Opioids Fentanyl Citrate, Heroin, And Both Opioids In Simulated Gastric Acid (vomit).

Pre-market Notification Details

Device IDK220371
510k NumberK220371
Device Name:Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested For Use With The Opioids Fentanyl Citrate, Heroin, And Both Opioids In Simulated Gastric Acid (Vomit)
ClassificationPolymer Patient Examination Glove
Applicant Summit Glove, Inc 310 South Grant Street Minerva,  OH  44657
ContactJames Hull
CorrespondentWava Truscott
Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell,  GA  30075
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-09
Decision Date2022-11-02

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