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
289–312 of 1954
Cleared Sep 11, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K011045
Shen Wei (Usa), Inc.
General Hospital · 159d
Cleared Sep 11, 2001
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
K011407
Sempermed USA, Inc.
General Hospital · 145d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K011044
Shen Wei (Usa), Inc.
General Hospital · 158d
Cleared Aug 22, 2001
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749
Sempermed USA, Inc.
General Hospital · 83d
Cleared Jul 31, 2001
POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K011995
Quality Latex Products Malaysia Sdn Bhd
General Hospital · 35d
Cleared Jul 17, 2001
LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
K011712
Pt.Shamrock Manufacturing Corp.
General Hospital · 43d
Cleared Jul 10, 2001
POWDER FREE LATEX EXAMINATION GLOVES
K010546
Jb Star Sdn Bhd
General Hospital · 137d
Cleared Jul 10, 2001
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
K011293
Multisafe Sdn. Bhd.
General Hospital · 71d
Cleared Jul 09, 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
K011728
Brightway Holdings Sdn. Bhd.
General Hospital · 35d
Cleared Jul 09, 2001
POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH
K011895
Pwa Industries Sdn. Bhd.
General Hospital · 21d
Cleared Jul 05, 2001
POWDERED LATEX EXAMINATION GLOVES
K011922
Seltom Pacific Sdn. Bhd.
General Hospital · 15d
Cleared Jun 13, 2001
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
K010854
Protection Gloves Sdn. Bhd.
General Hospital · 83d
Cleared Jun 13, 2001
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
K011231
Protection Gloves Sdn. Bhd.
General Hospital · 51d
Cleared Jun 07, 2001
HYCARE LATEX EXAMINATION GLOVE, POWDERED
K010875
Hycare Intl. Co., Ltd.
General Hospital · 76d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
K011370
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 06, 2001
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED
K010856
Brightway Holdings Sdn. Bhd.
General Hospital · 76d
Cleared Jun 05, 2001
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM
K011563
U.O.P. Rubber Products Sdn Bhd
General Hospital · 15d
Cleared May 31, 2001
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010961
Ansell Healthcare Products, Inc.
General Hospital · 62d
Cleared May 25, 2001
SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010947
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 57d
Cleared May 25, 2001
EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200
K011376
Yty Industry (Manjung) Sdn Bhd
General Hospital · 21d
Cleared May 16, 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010881
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 54d
Cleared May 11, 2001
SKINGARD POLYCOAT GLOVE
K004018
Top Quality Mfg., Inc.
General Hospital · 135d