FDA Product Code LYY: Latex Patient Examination Glove
A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 Medline Industries, Inc., Baxter Healthcare Corp and Sri Trang Gloves (Thailand) Public Company Limited.
1954
Total
1954
Cleared
104d
Avg days
1988
Since
Declining activity -
2 submissions in the last 2 years
vs 11 in the prior period
Review times increasing: avg
166d
recently vs 104d historically
FDA 510(k) Cleared Latex Patient Examination Glove Devices (Product Code LYY)
1954 devices
Cleared
Apr 29, 2025
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
109d
Cleared
Sep 09, 2024
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
222d
Cleared
Jun 13, 2023
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
Kossan International Sdn Bhd
General Hospital
104d
Cleared
Feb 22, 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Shandong Intco Medical Products Co, Ltd.
General Hospital
118d
Cleared
Nov 25, 2022
Powder-Free Latex examination gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
87d
Cleared
Oct 28, 2022
Non Sterile Powder Free Latex Examination Glove
New Era Medicare Sdn. Bhd.
General Hospital
142d
Cleared
Oct 27, 2022
JR MEDIC
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
85d
Cleared
Oct 26, 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital
167d
Cleared
Sep 24, 2022
Single-use medical latex examination gloves (LG100)
Fitone Latex Products Co., Ltd. Guangdong
General Hospital
18d
Cleared
Aug 25, 2022
Iconic Latex Glove
Iconic Medicare Sdn Bhd
General Hospital
79d
Cleared
Aug 22, 2022
Powder Free Latex Examination Glove, Non-Sterile
Wrp Asia Pacific Sdn. Bhd.
General Hospital
455d
Cleared
Aug 09, 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
365d
Cleared
Jul 14, 2022
Examination gloves-Type A(Latex gloves)
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
General Hospital
204d
Cleared
Jun 22, 2022
TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited
General Hospital
58d
Cleared
May 28, 2022
Amazing+ Latex Examination Powder Free Gloves
Amazing Rubber Products Pvt, Ltd.
General Hospital
285d
Cleared
Apr 24, 2022
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Avecena Gloves Sdn Bhd
General Hospital
143d
Cleared
Apr 08, 2022
Non-sterile, Powder-Free Latex Examination Glove
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
259d
Cleared
Apr 08, 2022
Latex Examination Gloves, Powder Free
Shandong Intco Medical Products Co, Ltd.
General Hospital
157d
Cleared
Dec 29, 2021
Goody Gloves, Wincare, TBG Gloves
Thai Rubber Gloves Co., Ltd.
General Hospital
97d
Cleared
Dec 07, 2021
Comfortpro
Thai Rubber Industry Company Limited
General Hospital
125d
Cleared
Nov 19, 2021
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
Pt. Universal Gloves
General Hospital
406d
Cleared
Nov 05, 2021
Best Glove-Latex Powder Free Examination Glove
Bestsafe Glove Co., Ltd.
General Hospital
280d
Cleared
Sep 20, 2021
Latex Examination Powder Free Gloves
Aspen Glove Sdn. Bhd.
General Hospital
131d
Cleared
Aug 20, 2021
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
Careplus (M) Sdn Bhd
General Hospital
245d
About Product Code LYY - Regulatory Context
510(k) Submission Activity
1954 total 510(k) submissions under product code LYY since 1988, with 1954 receiving FDA clearance (average review time: 104 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 11 in the prior period.
FDA 510(k) Review Time - LYY Product Code
Recent submissions under LYY have taken an average of 166 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.
LYY devices are reviewed by the General Hospital panel. Browse all General Hospital devices →