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
529–552 of 1181
Cleared Feb 22, 2017
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
K163041
Pt. Medisafe Technologies
General Hospital · 114d
Cleared Feb 22, 2017
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
K163126
Blue Sail Medical Co.,Ltd
General Hospital · 106d
Cleared Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491
Hartalega Sdn Bhd
General Hospital · 154d
Cleared Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
K162923
Hartalega NGC Sdn. Bhd.
General Hospital · 111d
Cleared Jan 31, 2017
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
K162381
Healthy Glove Co., Ltd.
General Hospital · 160d
Cleared Jan 24, 2017
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)
K162924
Hartalega Sdb. Bhd.
General Hospital · 98d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K162818
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K162819
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 05, 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K162146
Brightway Holdings Sdn. Bhd.
General Hospital · 157d
Cleared Dec 21, 2016
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
K161215
Brightway Holdings Sdn. Bhd.
General Hospital · 236d
Cleared Nov 28, 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
K161932
Terang Nusa Sdn Bhd
General Hospital · 137d
Cleared Nov 21, 2016
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K161944
Shandong Baisheng Medical Products Co., Ltd.
General Hospital · 129d
Cleared Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074
Shen Wei (Usa), Inc.
General Hospital · 213d
Cleared Nov 07, 2016
Powder Free Nitrile Examination Gloves (Blue)
K162113
Nam Viet Glove Joint Stock Company
General Hospital · 101d
Cleared Nov 02, 2016
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
K162095
Yty Industry (Manjung) Sdn Bhd
General Hospital · 97d
Cleared Oct 20, 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 150d
Cleared Oct 19, 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473
Medline Industries, Inc.
General Hospital · 145d
Cleared Oct 13, 2016
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
K160562
Hartalega Snd. Bhd.
General Hospital · 227d
Cleared Sep 09, 2016
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
K161187
Eco Medi Glove Sdn. Bhd.
General Hospital · 135d
Cleared Sep 01, 2016
EMG Pink Nitrile Examination Glove Powder Free
K161320
Eco Medi Glove Sdn. Bhd.
General Hospital · 113d
Cleared Aug 04, 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560
Hartalega Sdn Bhd
General Hospital · 157d
Cleared Aug 03, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
K151750
Kossan International Sdn Bhd
General Hospital · 401d
Cleared Aug 02, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K151824
Kossan International Sdn Bhd
General Hospital · 393d
Cleared Aug 02, 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K160467
Kossan International Sdn Bhd
General Hospital · 165d