510(k) Report

Devices descending from K050071

18 later devices reach Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063757Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd.200717—
+2K142992TULIP Natural Rubber Latex Surgeon's Glove (Powdered)Shanghai Jinxiang Latex Products Co., Ltd.20150—
+2K130301Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc.201314—
+2K113233Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling ClaimShen Wei (Usa), Inc.20120—
+3K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves…St. Marys Rubbers Pvt, Ltd.201512—
+3K150609Annuy Latex Surgeon's Gloves (Powdered and Powder Free)Anhui Anyu Latex Products Co., Ltd.20150—
+4K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Beta Healthcare Products Pvt., Ltd.201811—
+5K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.20208—
+5K190632Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or…Lenora Glove Pvt, Ltd.20191—
+6K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd.20221—
+6K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd20212—
+6K210969NulifeMrk Healthcare Pvt, Ltd.20210—
+6K211478Sterile Latex Surgical Gloves Powder FreeAspen Glove Sdn. Bhd.20210—
+6K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims…Eco Medi Glove Sdn. Bhd.20210—
+6K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical GlovesGuilin Hbm Health Protections, Inc.20210—
+7K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited20260—
+7K231446Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong20230—
+7K222620Sterilized Latex Surgical GlovesSuzhou Colour-Way New Material Co., Ltd.20230—