LYY · Class I · 21 CFR 880.6250

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 Wembley Rubber Products (M) Sdn Bhd, Siam Sempermed Corp., Ltd. and Hartalega Sdn Bhd.

1954
Total
1954
Cleared
104d
Avg days
1988
Since
1954 devices
25–48 of 1954
Cleared Aug 19, 2021
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
K211620
Shen Wei (Usa), Inc.
General Hospital · 85d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576
Pt. Universal Gloves
General Hospital · 342d
Cleared Dec 01, 2020
Palm Care Latex Examination Powder Free Gloves
K202377
Hi-Care Thai Gloves Co. , Ltd.
General Hospital · 103d
Cleared Nov 25, 2019
Blue Latex Examination Powder Free Gloves
K192329
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 90d
Cleared Jun 06, 2018
POWDER FREE LATEX EXAMINATION GLOVE
K173053
Professional Latex Sdn Bhd
General Hospital · 251d
Cleared Jan 26, 2018
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
K171367
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 262d
Cleared Aug 04, 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006
Hartalega Sdn Bhd
General Hospital · 115d
Cleared May 28, 2014
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953
Hartalega Sdn Bhd
General Hospital · 156d
Cleared May 07, 2013
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
K123368
Hartalega Sdn Bhd
General Hospital · 187d
Cleared Apr 21, 2011
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602
Medline Industries, Inc.
General Hospital · 134d
Cleared Jul 09, 2010
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
K100907
Siam Sempermed Corp., Ltd.
General Hospital · 99d
Cleared May 11, 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211
Shen Wei (Usa), Inc.
General Hospital · 106d
Cleared Sep 17, 2008
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Sep 03, 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K081907
Siam Sempermed Corp., Ltd.
General Hospital · 62d
Cleared Jul 19, 2005
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
K051329
Siam Sempermed Corp., Ltd.
General Hospital · 60d
Cleared Jun 07, 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277
Hartalega Sdn Bhd
General Hospital · 120d
Cleared Apr 28, 2004
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
K040645
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Nov 10, 2003
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
K030583
Shen Wei (Usa), Inc.
General Hospital · 259d
Cleared Feb 19, 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 34d
Cleared Jan 16, 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
K023490
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 92d
Cleared Jan 09, 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
K024292
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
K024106
Siam Sempermed Corp., Ltd.
General Hospital · 7d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
K024121
Siam Sempermed Corp., Ltd.
General Hospital · 4d
Cleared Dec 18, 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102
Allegiance Healthcare Corp.
General Hospital · 6d