FDA Product Code LYZ: Vinyl Patient Examination Glove
A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
Leading manufacturers include Shanghai Antares Industries, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Grand Work Plastic Products Co., Ltd..
799
Total
799
Cleared
98d
Avg days
1989
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg
41d
recently vs 98d historically
FDA 510(k) Cleared Vinyl Patient Examination Glove Devices (Product Code LYZ)
799 devices
Cleared
Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
Basic Medical Technology, Inc.
General Hospital
22d
Cleared
Oct 27, 2025
Disposable Vinyl Examination Gloves
Viet Phu Trade and Import Export Co., Ltd.
General Hospital
82d
Cleared
Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
Basic Medical Technology, Inc.
General Hospital
20d
Cleared
May 20, 2024
Disposable Vinyl Examination Gloves
Anqing Pukang Medical Technology Co., Ltd.
General Hospital
17d
Cleared
Mar 25, 2023
Vinyl examination gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
78d
Cleared
Feb 06, 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
Ever Global (Vietnam) Enterprise Corporation
General Hospital
216d
Cleared
Oct 19, 2022
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Ever Global (Vietnam) Enterprise Corporation
General Hospital
198d
Cleared
Oct 08, 2022
Disposable Vinyl Examination Gloves
Jiangxi Handspro Products Solutions Co., Ltd.
General Hospital
9d
Cleared
Sep 28, 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital
47d
Cleared
Aug 25, 2022
Disposable, vinyl examination gloves, Yellow
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital
231d
Cleared
Jun 16, 2022
Disposable Vinyl Examination Glove
Chifeng Huawei Medical Science&Technology Co., Ltd.
General Hospital
118d
Cleared
Mar 31, 2022
Vinyl Co-Polymer Powder-free Examination Gloves, Black
Grand Work Plastic Products Co., Ltd.
General Hospital
62d
Cleared
Feb 18, 2022
Vinyl/Nitrile Blend Exam Glove
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital
93d
Cleared
Feb 17, 2022
Vinyl Examination Gloves
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital
92d
Cleared
Feb 14, 2022
Vinyl Powder Free Examination Glove
Top Glove Vietnam Company Limited
General Hospital
231d
Cleared
Jan 05, 2022
Vinyl Exam Gloves
Hebei Astro Medical Supply Co., Ltd.
General Hospital
107d
Cleared
Dec 23, 2021
NBR Synthetic Nitrile Examination Gloves
Shandong Langtai International Trade Co., Ltd.
General Hospital
141d
Cleared
Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
Shen Wei (Usa), Inc.
General Hospital
86d
Cleared
Dec 21, 2021
Vinyl Examination Gloves
Taian Hengchang Medical Technology Co., Ltd.
General Hospital
92d
Cleared
Dec 20, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Liao Ning Shangwei Medical Products Co., Ltd.
General Hospital
187d
Cleared
Dec 11, 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Bytech Dongtai Co., Ltd.
General Hospital
89d
Cleared
Nov 26, 2021
Synthetic Nitrile Examination Gloves
Shandong Hongxin Chemicals Co., Ltd.
General Hospital
109d
Cleared
Nov 04, 2021
Powder Free Vinyl Examination Gloves
Shanghai Shengda Medical Applications Co., Ltd.
General Hospital
205d
Cleared
Oct 24, 2021
Vinyl Examination Gloves(Yellow)
Liuping Trading Co., Ltd.
General Hospital
143d
About Product Code LYZ - Regulatory Context
510(k) Submission Activity
799 total 510(k) submissions under product code LYZ since 1989, with 799 receiving FDA clearance (average review time: 98 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA 510(k) Review Time - LYZ Product Code
Recent submissions under LYZ have taken an average of 41 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.
LYZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →