FDA Product Code LZA: Polymer Patient Examination Glove
Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.
These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.
LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Shen Wei (Usa), Inc., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..
1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
Cleared
Jul 29, 2016
Powder Free Blue Nitrile Examination Glove
Qube Medical Product Sdn Bhd
General Hospital
214d
Cleared
Jun 23, 2016
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
Eco Medi Glove Sdn. Bhd.
General Hospital
262d
Cleared
Apr 14, 2016
Nitrile Patient Examination gloves, Powderfree, Blue color
Primus Gloves Pvt Limited
General Hospital
496d
Cleared
Apr 04, 2016
HG Pro Nitrile Powder Free Examination Gloves
Healthy Glove Co., Ltd.
General Hospital
217d
Cleared
Apr 01, 2016
Powder Free Blue Nitrile Examination Glove
Vietglove Corporation
General Hospital
109d
Cleared
Mar 31, 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
Hartalega NGC Sdn. Bhd.
General Hospital
255d
Cleared
Mar 31, 2016
Halyard Black-Orange Powder-Free Nitrile Exam Glove
Halyard Health
General Hospital
99d
Cleared
Mar 21, 2016
Powder Free Polychloroprene Examination Glove Green
Terang Nusa Sdn Bhd
General Hospital
105d
Cleared
Mar 17, 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
Jiayuan Medical Products Co., Ltd.
General Hospital
178d
Cleared
Mar 17, 2016
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
Minghao Medical Products Co., Ltd.
General Hospital
178d
Cleared
Mar 10, 2016
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
Xingda Medical Products Co., Ltd.
General Hospital
171d
Cleared
Mar 09, 2016
Nitrile Powder Free Patient Examination Gloves, Blue Color
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
170d
Cleared
Feb 25, 2016
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
Haining Medical Products Co., Ltd.
General Hospital
157d
Cleared
Feb 12, 2016
Powder Free Nitrile Patient Examination Gloves, Blue Color
Suqian Xingye Glove Co,Ltd
General Hospital
235d
Cleared
Feb 09, 2016
Powder Free Nitrile Patient Examination Gloves, Black color
Suqian Xingye Glove Co,Ltd
General Hospital
181d
Cleared
Dec 24, 2015
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
Riverstone Resources Sdn Bhd
General Hospital
111d
Cleared
Oct 21, 2015
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
Hartalega NGC Sdn. Bhd.
General Hospital
107d
Cleared
Oct 09, 2015
Powder Free Nitrile (Black) Examination Gloves
Gallant Quality Sdn. Bhd.
General Hospital
123d
Cleared
Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
88d
Cleared
Sep 14, 2015
Powder Free Nitrile Examination Glove
Vrg Khai Hoan Joint Stock Company
General Hospital
131d
Cleared
Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
Hartalega NGC Sdn. Bhd.
General Hospital
97d
Cleared
Aug 18, 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
Yty Industry (Manjung) Sdn Bhd
General Hospital
274d
Cleared
Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
Halyard Health
General Hospital
149d
Cleared
Jun 18, 2015
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
Hebei Hongsen Plastics Technology Co, Ltd.
General Hospital
127d