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Appendix III. 510(k) Summary

510(k) Number: ('< 2 ' Device Name: Latex Examination Gloves (Powdered and Powder-Free) Nitrile Examination Gloves (Powdered and Powder-Free) Indications for Use: A patient examination glove is disposable devices intended for medical purpose that is worn on the hand or finger(s) to prevent contamination between patient and examiner.