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
385–408 of 1954
Cleared Apr 28, 2000
SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
K001094
Jb Star Sdn Bhd
General Hospital · 24d
Cleared Apr 28, 2000
POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K001216
Fitco Dipped Products Pvt., Ltd.
General Hospital · 14d
Cleared Apr 24, 2000
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
K000985
Matang Mfg. Sdn. Bhd.
General Hospital · 28d
Cleared Apr 21, 2000
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
K000867
Sgmp Co., Ltd.
General Hospital · 35d
Cleared Apr 20, 2000
BETEL POWDER FREE LATEX EXAM GLOVES
K000650
Betel Care Sdn. Bhd.
General Hospital · 52d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K000390
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000391
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
K000555
Tekmedic (M) Sdn Bhd
General Hospital · 54d
Cleared Apr 12, 2000
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000584
Shasta Asia Partners Gloves Manufacturing CO , Ltd.
General Hospital · 50d
Cleared Apr 12, 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
K991677
London International Group, Inc.
General Hospital · 331d
Cleared Apr 10, 2000
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K000652
Betel Care Sdn. Bhd.
General Hospital · 42d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Apr 05, 2000
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K000725
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 30d
Cleared Mar 29, 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
K000671
Sgmp Co., Ltd.
General Hospital · 30d
Cleared Mar 20, 2000
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
K000488
Sgmp Co., Ltd.
General Hospital · 35d
Cleared Mar 17, 2000
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
K000644
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 21d
Cleared Mar 10, 2000
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K000165
Ansell Perry
General Hospital · 51d
Cleared Mar 02, 2000
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
K993117
Safeskin Corp.
General Hospital · 164d
Cleared Mar 02, 2000
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
K993811
Multisafe Sdn. Bhd.
General Hospital · 113d
Cleared Feb 18, 2000
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
K000156
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 30d
Cleared Feb 18, 2000
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
K000217
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 25d
Cleared Feb 16, 2000
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
K994432
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 48d
Cleared Feb 10, 2000
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
K000090
Guthrie Medicare Products (Melaka) Sdn Bhd
General Hospital · 28d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918
Pamitex Industries Sdn Bhd
General Hospital · 84d