LYZ · Class I · 21 CFR 880.6250

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 Bd Becton Dickinson Vacutainer Systems Preanalytic, Medline Industries, Inc. and Baxter Healthcare Corp.

799
Total
799
Cleared
98d
Avg days
1989
Since
Declining activity - 3 submissions in the last 2 years vs 7 in the prior period
Review times improving: avg 41d recently vs 98d historically

FDA 510(k) Cleared Vinyl Patient Examination Glove Devices (Product Code LYZ)

799 devices
1–24 of 799
Cleared Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860
Basic Medical Technology, Inc.
General Hospital · 22d
Cleared Oct 27, 2025
Disposable Vinyl Examination Gloves
K252467
Viet Phu Trade and Import Export Co., Ltd.
General Hospital · 82d
Cleared Aug 28, 2025
Powder-Free Vinyl Exam Gloves, clear
K252505
Basic Medical Technology, Inc.
General Hospital · 20d
Cleared May 20, 2024
Disposable Vinyl Examination Gloves
K241252
Anqing Pukang Medical Technology Co., Ltd.
General Hospital · 17d
Cleared Mar 25, 2023
Vinyl examination gloves
K230046
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 78d
Cleared Feb 06, 2023
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K221980
Ever Global (Vietnam) Enterprise Corporation
General Hospital · 216d
Cleared Oct 19, 2022
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992
Ever Global (Vietnam) Enterprise Corporation
General Hospital · 198d
Cleared Oct 08, 2022
Disposable Vinyl Examination Gloves
K223008
Jiangxi Handspro Products Solutions Co., Ltd.
General Hospital · 9d
Cleared Sep 28, 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 47d
Cleared Aug 25, 2022
Disposable, vinyl examination gloves, Yellow
K220055
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital · 231d
Cleared Jun 16, 2022
Disposable Vinyl Examination Glove
K220469
Chifeng Huawei Medical Science&Technology Co., Ltd.
General Hospital · 118d
Cleared Mar 31, 2022
Vinyl Co-Polymer Powder-free Examination Gloves, Black
K220240
Grand Work Plastic Products Co., Ltd.
General Hospital · 62d
Cleared Feb 18, 2022
Vinyl/Nitrile Blend Exam Glove
K213634
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital · 93d
Cleared Feb 17, 2022
Vinyl Examination Gloves
K213625
Dezhou Hengchang Medical Technology Co., Ltd.
General Hospital · 92d
Cleared Feb 14, 2022
Vinyl Powder Free Examination Glove
K212011
Top Glove Vietnam Company Limited
General Hospital · 231d
Cleared Jan 05, 2022
Vinyl Exam Gloves
K213019
Hebei Astro Medical Supply Co., Ltd.
General Hospital · 107d
Cleared Dec 23, 2021
NBR Synthetic Nitrile Examination Gloves
K212436
Shandong Langtai International Trade Co., Ltd.
General Hospital · 141d
Cleared Dec 22, 2021
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
K213144
Shen Wei (Usa), Inc.
General Hospital · 86d
Cleared Dec 21, 2021
Vinyl Examination Gloves
K213006
Taian Hengchang Medical Technology Co., Ltd.
General Hospital · 92d
Cleared Dec 20, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K211865
Liao Ning Shangwei Medical Products Co., Ltd.
General Hospital · 187d
Cleared Dec 11, 2021
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
K212899
Bytech Dongtai Co., Ltd.
General Hospital · 89d
Cleared Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 109d
Cleared Nov 04, 2021
Powder Free Vinyl Examination Gloves
K211103
Shanghai Shengda Medical Applications Co., Ltd.
General Hospital · 205d
Cleared Oct 24, 2021
Vinyl Examination Gloves(Yellow)
K211698
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 declined in recent years - 3 submissions in the last 24 months compared to 7 in the prior period.

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 →