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
217–240 of 1954
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
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918
Pamitex Industries Sdn Bhd
General Hospital · 84d
Cleared Feb 09, 2000
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
K993912
Latexx Partners, Inc.
General Hospital · 84d
Cleared Feb 09, 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
K994162
Allegiance Healthcare Corp.
General Hospital · 62d
Cleared Feb 07, 2000
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)
K994131
Medtaxx Partners
General Hospital · 62d
Cleared Feb 07, 2000
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K994201
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 56d
Cleared Feb 07, 2000
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994250
Tekmedic (M) Sdn Bhd
General Hospital · 53d
Cleared Feb 07, 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255
Pt. Maja Agung Latexindo
General Hospital · 52d
Cleared Feb 03, 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416
Flexitech Sdn. Bhd.
General Hospital · 36d
Cleared Jan 31, 2000
POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K994354
Flexitech Sdn. Bhd.
General Hospital · 39d
Cleared Jan 28, 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082
Besglove Medicare Sdn. Bhd.
General Hospital · 56d
Cleared Jan 20, 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K994013
Glovco (M) Sdn. Bhd.
General Hospital · 55d
Cleared Jan 12, 2000
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
K993567
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Jan 12, 2000
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
K993793
Guthrie Medicare Products (Melaka) Sdn Bhd
General Hospital · 64d
Cleared Jan 11, 2000
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
K994043
Biopro (M) Sdn Bhd
General Hospital · 43d
Cleared Dec 29, 1999
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K993529
Biografik (Malaysia) Sdn Bhd
General Hospital · 72d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
K993621
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 20, 1999
LATEX EXAMINATION POWDERED GLOVES
K993386
Great Glove Sdn Bhd
General Hospital · 73d
Cleared Dec 20, 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452
Top Glove Sdn. Bhd.
General Hospital · 68d
Cleared Dec 20, 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605
Top Glove Sdn. Bhd.
General Hospital · 56d
Cleared Dec 16, 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 128d