Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

Polymer Patient Examination Glove

American Nitrile Operations LLC

The following data is part of a premarket notification filed by American Nitrile Operations Llc with the FDA for Sapphire Pro Powder-free Royal Blue Nitrile Exam Gloves.

Pre-market Notification Details

Device IDK220825
510k NumberK220825
Device Name:Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
ClassificationPolymer Patient Examination Glove
Applicant American Nitrile Operations LLC 3500 Southwest Blvd Grove City,  OH  43123
ContactStephen Perrin
CorrespondentStephen Perrin
American Nitrile Operations LLC 3500 Southwest Blvd Grove City,  OH  43123
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-21
Decision Date2022-07-08

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