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
745–768 of 1954
Cleared May 10, 1995
ANDAL
K950823
Pt. Sarana Indoprotex
General Hospital · 76d
Cleared Apr 28, 1995
SCIPOTEX
K945785
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 154d
Cleared Apr 28, 1995
SCIPOTEX (PINK)
K951455
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 30d
Cleared Apr 28, 1995
SCIPOTEX (BLUE)
K951456
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 30d
Cleared Apr 28, 1995
ULTIMAX
K951467
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Apr 28, 1995
COMFIT
K951468
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Apr 25, 1995
PROSHIELD PLUS MULTIPLE
K946111
Sino (U.S.A.) Co.
General Hospital · 131d
Cleared Apr 25, 1995
POWDER FREE PATIENT EXAMINATION GLOVES
K950467
Intl. Trade Management Co.
General Hospital · 81d
Cleared Apr 13, 1995
COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936266
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 469d
Cleared Apr 13, 1995
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)
K951137
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 31d
Cleared Apr 13, 1995
SCIPOTEX
K951171
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 29d
Cleared Mar 31, 1995
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE
K950254
Cypress Medical Products, Ltd.
General Hospital · 67d
Cleared Mar 23, 1995
PATIENT EXAMINATION GLOVES
K945885
Hartalega Sdn Bhd
General Hospital · 112d
Cleared Mar 07, 1995
COMFIT BLUE POWDER FREE EXAMINATION GLOVES
K943563
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Mar 02, 1995
POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945767
Ansell, Inc.
General Hospital · 101d
Cleared Feb 28, 1995
DISPOSABLE LATEX EXAM GLOVES
K941557
Dah Lee Investments, Ltd.
General Hospital · 334d
Cleared Feb 27, 1995
JAI POWDERFREE LATEX EXAMINATION GLOVES
K946203
Intl. Trade Management Co.
General Hospital · 68d
Cleared Feb 24, 1995
COMFIT BLUE POWERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936295
Wembley Rubber Products
General Hospital · 424d
Cleared Feb 24, 1995
ULTIMAX POWDER FREE EXAMINATION GLOVES
K943451
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 221d
Cleared Feb 21, 1995
ULTIMAX (GREEN POWDER FREE EXAMINATION)
K943869
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 197d
Cleared Feb 03, 1995
SCIPOTEX POWDER FREE EXAM GLOVES (BEADED)
K942511
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 253d
Cleared Feb 03, 1995
SCIPOTEX
K943868
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 179d
Cleared Feb 03, 1995
MULTIPLE
K945164
Protection Gloves Sdn. Bhd.
General Hospital · 105d
Cleared Jan 17, 1995
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)
K946155
Mala Intertrade Co., Ltd.
General Hospital · 32d