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
649–672 of 1954
Cleared Feb 25, 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297
Omni Sales Corp.
General Hospital · 29d
Cleared Feb 10, 1997
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
K963866
Supertex Industrial, S.A. DE C.V.
General Hospital · 210d
Cleared Feb 07, 1997
AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
K962737
Supertex Industrial, S.A. DE C.V.
General Hospital · 207d
Cleared Jan 24, 1997
MEDTEXX
K963331
Regalfield Sdn. Bhd.
General Hospital · 154d
Cleared Jan 24, 1997
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES
K964317
Nantong Ruchang Latex Products Co., Ltd.
General Hospital · 87d
Cleared Jan 24, 1997
DERLIN
K964817
Derlin Company , Ltd.
General Hospital · 56d
Cleared Dec 30, 1996
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
K955425
Dash Medical Gloves Sdn Bhd
General Hospital · 398d
Cleared Dec 30, 1996
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K964563
Omni Sales Corp.
General Hospital · 46d
Cleared Nov 22, 1996
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
K963211
American Healthcare Products, Inc.
General Hospital · 98d
Cleared Nov 20, 1996
FLAVORED LATEX PATIENT EXAMINATION
K960315
P.T. Irama Dinamika Latex
General Hospital · 302d
Cleared Nov 20, 1996
LATEX EXAMINATION GLOVES, POWDERED
K963742
Arista Medi Prima
General Hospital · 64d
Cleared Nov 19, 1996
MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962096
Medline Industries, Inc.
General Hospital · 175d
Cleared Oct 31, 1996
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
K960590
Aladan Corp.
General Hospital · 262d
Cleared Oct 24, 1996
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K963560
Pwa Industries Sdn. Bhd.
General Hospital · 49d
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 Aug 20, 1996
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953955
Codan Medlon, Inc.
General Hospital · 371d
Cleared Aug 20, 1996
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953956
Codan Medlon, Inc.
General Hospital · 371d