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
73–96 of 1954
Cleared Jan 26, 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 561d
Cleared Jan 26, 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145
Shen Wei (Usa), Inc.
General Hospital · 140d
Cleared Nov 20, 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975
Siam Sempermed Corp., Ltd.
General Hospital · 168d
Cleared Mar 13, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572
Hartalega Sdn Bhd
General Hospital · 24d
Cleared Mar 11, 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318
Hartalega Sdn Bhd
General Hospital · 43d
Cleared Dec 11, 1997
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778
Hartalega Sdn Bhd
General Hospital · 69d
Cleared Dec 11, 1997
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871
Hartalega Sdn Bhd
General Hospital · 62d
Cleared Jul 28, 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291
Allegiance Healthcare Corp.
General Hospital · 39d
Cleared May 06, 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Nov 19, 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096
Medline Industries, Inc.
General Hospital · 175d
Cleared Oct 11, 1996
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
K953213
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 459d
Cleared Oct 11, 1996
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K954416
Hartalega Sdn Bhd
General Hospital · 386d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
K961415
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Oct 07, 1996
LATEX PATIENT EXAMINATION GLOVE (PINK)
K961602
Siam Sempermed Corp., Ltd.
General Hospital · 186d
Cleared Sep 17, 1996
LATEX PATIENT EXAMINATION GLOVE
K960942
Siam Sempermed Corp., Ltd.
General Hospital · 217d
Cleared Aug 23, 1996
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
K962076
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962094
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
K962095
Medline Industries, Inc.
General Hospital · 87d
Cleared Jul 26, 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jul 26, 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jun 27, 1996
COMFIT
K953590
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 332d
Cleared May 24, 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467
Biopro, Inc.
General Hospital · 115d
Cleared May 03, 1996
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221
Hartalega Sdn Bhd
General Hospital · 235d
Cleared Mar 12, 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415
Hartalega Sdn Bhd
General Hospital · 173d