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 Hartalega Sdn Bhd.

1954
Total
1954
Cleared
104d
Avg days
1988
Since
1954 devices
97–120 of 1954
Cleared Aug 07, 2008
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
K080606
Alatech Healthcare, LLC
General Hospital · 156d
Cleared May 20, 2008
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K081040
Pt.Shamrock Manufacturing Corp.
General Hospital · 39d
Cleared May 16, 2008
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
K072300
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 273d
Cleared Apr 15, 2008
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
K072614
Matang Mfg. Sdn. Bhd.
General Hospital · 211d
Cleared Mar 27, 2008
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
K072403
Sgmp Co., Ltd.
General Hospital · 213d
Cleared Mar 21, 2008
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
K072406
Sgmp Co., Ltd.
General Hospital · 207d
Cleared Mar 05, 2008
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
K073299
Betel Care Sdn. Bhd.
General Hospital · 103d
Cleared Feb 29, 2008
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
K072802
Ultrawin Sdn Bhd
General Hospital · 151d
Cleared Feb 26, 2008
MEDICAL GLOVE SERIES
K072145
Zhanjiang Jiali Glove Products Co., Ltd.
General Hospital · 208d
Cleared Nov 19, 2007
YUYUAN LATEX EXAMINATION GLOVE, POWDERED
K072639
Shandong Yuyuan Latex Gloves Company , Ltd.
General Hospital · 62d
Cleared Jul 26, 2007
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
K071060
Sgmp Co., Ltd.
General Hospital · 101d
Cleared Jul 25, 2007
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
K071209
High Momentum Sdn Bhd
General Hospital · 85d
Cleared Jul 13, 2007
POWDER FREE LATEX EXAMINATION GLOVES
K071322
Quality Gallant Sdn. Bhd.
General Hospital · 64d
Cleared Jun 22, 2007
POWDERED LATEX EXAMINATION GLOVES
K071323
Quality Gallant Sdn. Bhd.
General Hospital · 43d
Cleared Jun 07, 2007
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
K070760
Derma Care Plus Products, LLC
General Hospital · 79d
Cleared May 10, 2007
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
K070821
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 45d
Cleared Apr 13, 2007
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K062526
Multisafe Sdn. Bhd.
General Hospital · 228d
Cleared Mar 15, 2007
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
K063581
Pt Mahakarya Inti Buana
General Hospital · 105d
Cleared Mar 15, 2007
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
K070072
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 66d
Cleared Mar 02, 2007
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
K063776
Bright Element Sdn Bhd
General Hospital · 71d
Cleared Feb 20, 2007
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K062527
Multisafe Sdn. Bhd.
General Hospital · 176d
Cleared Dec 22, 2006
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062965
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 84d
Cleared Dec 06, 2006
POWDER FREE LATEX EXAMINATION GLOVES, BLACK
K062709
Pt. Maja Agung Latexindo
General Hospital · 86d
Cleared Nov 30, 2006
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
K062313
Pt Mahakarya Inti Buana
General Hospital · 114d