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

265–288 of 1954

Cleared Oct 18, 1999

HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W

Pamitex Industries Sdn Bhd

General Hospital · 82d

Cleared Oct 15, 1999

POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI

Alliance Rubber Products Sdn. Bhd.

General Hospital · 50d

Cleared Oct 06, 1999

HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA

Pamitex Industries Sdn Bhd

General Hospital · 162d

Cleared Sep 27, 1999

PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER

Pamitex Industries Sdn Bhd

General Hospital · 96d

Cleared Sep 27, 1999

HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE

Hwa Teh Industrial Sdn. Bhd.

General Hospital · 38d

Cleared Sep 24, 1999

EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED

Ultrawin Sdn Bhd

General Hospital · 88d

Cleared Sep 22, 1999

HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O

Pamitex Industries Sdn Bhd

General Hospital · 69d

Cleared Sep 14, 1999

DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS

Dash Medical Gloves Sdn Bhd

General Hospital · 83d

Cleared Sep 14, 1999

QUALATEX POWDERED LATEX EXAMINATION GLOVES

Tan Sin Lian Industries Sdn. Bhd.

General Hospital · 46d

Cleared Sep 14, 1999

HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE

Hwa Teh Industrial Sdn. Bhd.

General Hospital · 32d

Cleared Sep 13, 1999

ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

Shield Gloves Manufacturer (M) Sdn Bhd

General Hospital · 55d

Cleared Sep 13, 1999

ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI

Shield Gloves Manufacturer (M) Sdn Bhd

General Hospital · 55d

Cleared Sep 13, 1999

ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR

Shield Gloves Manufacturer (M) Sdn Bhd

General Hospital · 55d

Cleared Sep 10, 1999

CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)

Biopro (M) Sdn Bhd

General Hospital · 58d

Cleared Sep 09, 1999

HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)

Pamitex Industries Sdn Bhd

General Hospital · 90d

Cleared Aug 31, 1999

LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)

Seltom Pacific Sdn. Bhd.

General Hospital · 98d

Cleared Aug 31, 1999

LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)

Seltom Pacific Sdn. Bhd.

General Hospital · 98d

Cleared Aug 25, 1999

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE

Pamitex Industries Sdn Bhd

General Hospital · 58d

Cleared Aug 17, 1999

TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

Shen Wei (Usa), Inc.

General Hospital · 48d

Cleared Aug 09, 1999

ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE

Tillotson Healthcare Corp.

General Hospital · 19d

Cleared Jul 14, 1999

CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Hartalega Sdn Bhd

General Hospital · 65d

Cleared Jul 12, 1999

LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)

Shanghai Changzheng Latex Factory

General Hospital · 26d

Cleared Jul 09, 1999

GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

Glovco (M) Sdn. Bhd.

General Hospital · 67d

Cleared Jul 09, 1999

POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES

Smart Glove Corp. Sdn Bhd

General Hospital · 59d