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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..
1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
Cleared
Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
O&M Halyard, Inc.
General Hospital
175d
Cleared
Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
Top Glove Sdn. Bhd.
General Hospital
395d
Cleared
Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
57d
Cleared
Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
Anhui Lntco Medical Products Co., Ltd.
General Hospital
217d
Cleared
Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Hartalega NGC Sdn. Bhd.
General Hospital
58d
Cleared
Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega Sdn Bhd
General Hospital
58d
Cleared
Aug 04, 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff
Medline Industries, Inc.
General Hospital
217d
Cleared
Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
Medline Industires, Inc.
General Hospital
94d
Cleared
Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
242d
Cleared
Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
Ansell Healthcare Products, LLC
General Hospital
98d
Cleared
Jun 06, 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
Mercator Medical (Thailand), Ltd.
General Hospital
57d
Cleared
Jun 05, 2020
Latex Examination Powder Free Glove, Aloe Vera
Top Glove Sdn. Bhd.
General Hospital
205d
Cleared
May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
Yty Industry (Manjung) Sdn Bhd
General Hospital
67d
Cleared
Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
51d
Cleared
Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
82d
Cleared
Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
Kimberly Clark Corporation
General Hospital
87d
Cleared
Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
Riverstone Resources Sdn Bhd
General Hospital
59d
Cleared
Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
37d
Cleared
Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Hartalega NGC Sdn. Bhd.
General Hospital
94d
Cleared
Mar 20, 2020
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
Eco Medi Glove Sdn. Bhd.
General Hospital
129d
Cleared
Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital
88d
Cleared
Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
Medline Industries, Inc.
General Hospital
260d
Cleared
Mar 13, 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
O&M Haylard, Inc.
General Hospital
207d
Cleared
Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
150d