510(k) Report

Devices descending from K151114

12 later devices reach Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Beta Healthcare Products Pvt., Ltd.201811—
+2K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.20208—
+2K190632Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or…Lenora Glove Pvt, Ltd.20191—
+3K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd.20221—
+3K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd20212—
+3K210969NulifeMrk Healthcare Pvt, Ltd.20210—
+3K211478Sterile Latex Surgical Gloves Powder FreeAspen Glove Sdn. Bhd.20210—
+3K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims…Eco Medi Glove Sdn. Bhd.20210—
+3K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.20210—
+4K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited20260—
+4K231446Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong20230—
+4K222620Sterilized Latex Surgical GlovesSuzhou Colour-Way New Material Co., Ltd.20230—