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, Sgmp Co., Ltd. and Siam Sempermed Corp., Ltd..

1954
Total
1954
Cleared
104d
Avg days
1988
Since
1954 devices
121–144 of 1954
Cleared Nov 30, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062688
Ug Healthcare (Usa), Inc.
General Hospital · 83d
Cleared Nov 09, 2006
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K062955
Pt. Haloni Jane
General Hospital · 41d
Cleared Nov 03, 2006
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
K061233
Pt Mahakarya Inti Buana
General Hospital · 185d
Cleared Nov 02, 2006
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
K062917
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 35d
Cleared Aug 24, 2006
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
K061551
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 80d
Cleared Jun 08, 2006
LATEX POWDERED EXAMINATION GLOVE
K060858
High Momentum Sdn Bhd
General Hospital · 71d
Cleared Jun 02, 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
K053305
Pt Mahakarya Inti Buana
General Hospital · 186d
Cleared May 19, 2006
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
K061078
Bright Element Sdn Bhd
General Hospital · 32d
Cleared May 16, 2006
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
K060775
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 55d
Cleared Apr 10, 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
K060658
Brightway Holdings Sdn. Bhd.
General Hospital · 54d
Cleared Mar 15, 2006
POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
K060229
Shun Thai Rubber Gloves Industry Public Co., Ltd.
General Hospital · 44d
Cleared Jan 25, 2006
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
K052666
Ascend Eagle, Inc.
General Hospital · 120d
Cleared Dec 06, 2005
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
K050526
Spi Gloves Sdn. Bhd.
General Hospital · 279d
Cleared Dec 05, 2005
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
K052728
M/S. Kanam Latex Industries Pvt. , Ltd.
General Hospital · 67d
Cleared Nov 08, 2005
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
K052709
Pt.Shamrock Manufacturing Corp.
General Hospital · 40d
Cleared Oct 06, 2005
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K051987
Pt. Mandiri Inti Buana
General Hospital · 76d
Cleared Sep 30, 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051913
Shinemound Enterprise, Inc.
General Hospital · 77d
Cleared Sep 30, 2005
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K052273
Pt Mahakarya Inti Buana
General Hospital · 39d
Cleared Sep 27, 2005
B-CARE POWDER FREE LATEX EXAMINATION GLOVES
K051404
B-Care Industries Co., Ltd.
General Hospital · 119d
Cleared Sep 13, 2005
PRE-POWDERED STERILE EXAM GLOVES
K052214
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 29d
Cleared Sep 01, 2005
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
K052016
Sgmp Co., Ltd.
General Hospital · 37d
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 Jul 12, 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051465
P.T. Anlis Abadi Internasional
General Hospital · 39d
Cleared Jun 23, 2005
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
K051345
Glovco (M) Sdn. Bhd.
General Hospital · 31d