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
Feb 22, 2017
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
Pt. Medisafe Technologies
General Hospital
114d
Cleared
Feb 22, 2017
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
Blue Sail Medical Co.,Ltd
General Hospital
106d
Cleared
Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega Sdn Bhd
General Hospital
154d
Cleared
Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE
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
Healthy Glove Co., Ltd.
General Hospital
160d
Cleared
Jan 24, 2017
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)
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)
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
Hartalega Sdn Bhd
General Hospital
95d
Cleared
Jan 05, 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
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
Brightway Holdings Sdn. Bhd.
General Hospital
236d
Cleared
Nov 28, 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
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
Shandong Baisheng Medical Products Co., Ltd.
General Hospital
129d
Cleared
Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
Shen Wei (Usa), Inc.
General Hospital
213d
Cleared
Nov 07, 2016
Powder Free Nitrile Examination Gloves (Blue)
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)
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
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)
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
Hartalega Snd. Bhd.
General Hospital
227d
Cleared
Sep 09, 2016
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
Eco Medi Glove Sdn. Bhd.
General Hospital
135d
Cleared
Sep 01, 2016
EMG Pink Nitrile Examination Glove Powder Free
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)
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
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
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
Kossan International Sdn Bhd
General Hospital
165d