DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE

About This 510(k) Submission

K133168 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on August 7, 2014, 294 days after receiving the submission on October 17, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.