LZA · Class I · 21 CFR 880.6250

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
553–576 of 1181
Cleared Jul 29, 2016
Powder Free Blue Nitrile Examination Glove
K153732
Qube Medical Product Sdn Bhd
General Hospital · 214d
Cleared Jun 23, 2016
EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
K152937
Eco Medi Glove Sdn. Bhd.
General Hospital · 262d
Cleared Apr 14, 2016
Nitrile Patient Examination gloves, Powderfree, Blue color
K143477
Primus Gloves Pvt Limited
General Hospital · 496d
Cleared Apr 04, 2016
HG Pro Nitrile Powder Free Examination Gloves
K152479
Healthy Glove Co., Ltd.
General Hospital · 217d
Cleared Apr 01, 2016
Powder Free Blue Nitrile Examination Glove
K153562
Vietglove Corporation
General Hospital · 109d
Cleared Mar 31, 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997
Hartalega NGC Sdn. Bhd.
General Hospital · 255d
Cleared Mar 31, 2016
Halyard Black-Orange Powder-Free Nitrile Exam Glove
K153708
Halyard Health
General Hospital · 99d
Cleared Mar 21, 2016
Powder Free Polychloroprene Examination Glove Green
K153510
Terang Nusa Sdn Bhd
General Hospital · 105d
Cleared Mar 17, 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
K152705
Jiayuan Medical Products Co., Ltd.
General Hospital · 178d
Cleared Mar 17, 2016
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
K152707
Minghao Medical Products Co., Ltd.
General Hospital · 178d
Cleared Mar 10, 2016
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color
K152720
Xingda Medical Products Co., Ltd.
General Hospital · 171d
Cleared Mar 09, 2016
Nitrile Powder Free Patient Examination Gloves, Blue Color
K152712
Zhonghong Pulin Medical Products Co., Ltd.
General Hospital · 170d
Cleared Feb 25, 2016
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K152715
Haining Medical Products Co., Ltd.
General Hospital · 157d
Cleared Feb 12, 2016
Powder Free Nitrile Patient Examination Gloves, Blue Color
K151680
Suqian Xingye Glove Co,Ltd
General Hospital · 235d
Cleared Feb 09, 2016
Powder Free Nitrile Patient Examination Gloves, Black color
K152271
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
K152542
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
K151836
Hartalega NGC Sdn. Bhd.
General Hospital · 107d
Cleared Oct 09, 2015
Powder Free Nitrile (Black) Examination Gloves
K151528
Gallant Quality Sdn. Bhd.
General Hospital · 123d
Cleared Sep 18, 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue)
K151684
Hartalega NGC Sdn. Bhd.
General Hospital · 88d
Cleared Sep 14, 2015
Powder Free Nitrile Examination Glove
K151208
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)
K151343
Hartalega NGC Sdn. Bhd.
General Hospital · 97d
Cleared Aug 18, 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
K143289
Yty Industry (Manjung) Sdn Bhd
General Hospital · 274d
Cleared Jun 18, 2015
Fusion Black Powder-Free Nitrile Exam Glove
K150113
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)
K150340
Hebei Hongsen Plastics Technology Co, Ltd.
General Hospital · 127d