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
121–144 of 1954
Cleared Jan 09, 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
K024292
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIM
K024106
Siam Sempermed Corp., Ltd.
General Hospital · 7d
Cleared Dec 20, 2002
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
K024121
Siam Sempermed Corp., Ltd.
General Hospital · 4d
Cleared Dec 18, 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102
Allegiance Healthcare Corp.
General Hospital · 6d
Cleared Dec 06, 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
K023577
Yty Industry (Manjung) Sdn Bhd
General Hospital · 44d
Cleared Nov 08, 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590
Yty Industry (Manjung) Sdn Bhd
General Hospital · 14d
Cleared Oct 28, 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
K023262
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Oct 21, 2002
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K022987
Arista Latindo Industrial Ltd. P.T
General Hospital · 42d
Cleared Oct 03, 2002
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
K022808
Wrp Specialty Products Sdn. Bhd.
General Hospital · 41d
Cleared Sep 23, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220
Shen Wei (Usa), Inc.
General Hospital · 76d
Cleared Sep 17, 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
K022088
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K022092
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Aug 26, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 21d
Cleared Aug 05, 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
K021855
Top Glove Sdn. Bhd.
General Hospital · 60d
Cleared Jul 05, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818
Allegiance Healthcare Corp.
General Hospital · 114d
Cleared Jul 05, 2002
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL
K021007
Tillotson Healthcare Corp.
General Hospital · 99d
Cleared Jul 02, 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES
K021521
Smart Glove Corp. Sdn Bhd
General Hospital · 53d
Cleared Jun 11, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
K021561
Wrp Specialty Products Sdn. Bhd.
General Hospital · 29d
Cleared Jun 10, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
K021536
Wrp Specialty Products Sdn. Bhd.
General Hospital · 31d
Cleared Jun 07, 2002
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED
K021412
Arista Latindo Industrial Ltd. P.T
General Hospital · 35d
Cleared May 14, 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021058
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d