510(k) Report

Devices descending from K011377

3 later devices reach Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052016Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination…Sgmp Co., Ltd.20052—
+2K071060Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and…Sgmp Co., Ltd.20071—
+3K093375KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling…Koon Seng Sdn Bhd20090—