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
May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Encompass Industries Sdn. Bhd.
General Hospital
86d
Cleared
May 26, 2022
PP Care Nitrile Examination Gloves
Eg Group Product and Services Co., Ltd.
General Hospital
280d
Cleared
May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Grand Work Plastic Products Co., Ltd.
General Hospital
115d
Cleared
May 23, 2022
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Pt. Shamrock Manufacturing Corpora
General Hospital
346d
Cleared
May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Motex Healthcare (Anhui) Co., Ltd.
General Hospital
124d
Cleared
May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Pt. Maja Agung Latexindo
General Hospital
288d
Cleared
May 18, 2022
Nitrile Powder Free Examination Gloves
Hebei Kangxida Medical Technology Development Co., Ltd.
General Hospital
112d
Cleared
May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd
General Hospital
87d
Cleared
May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital
118d
Cleared
May 12, 2022
Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment Co., Ltd.
General Hospital
85d
Cleared
May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd.
General Hospital
100d
Cleared
May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd
General Hospital
84d
Cleared
May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd
General Hospital
84d
Cleared
Apr 27, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
217d
Cleared
Apr 21, 2022
Ivory Glove Powder-Free Nitrile Examination Gloves
Ivory Gloves Sdn. Bhd.
General Hospital
150d
Cleared
Apr 21, 2022
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
Jiangsu Bytech Medical Supplies Co., Ltd.
General Hospital
70d
Cleared
Apr 17, 2022
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
Meditech Gloves Sdn Bhd
General Hospital
180d
Cleared
Apr 14, 2022
Disposable Medical Nitrile Examination Gloves
Nanjing Universal Medical Equipment Co., Ltd.
General Hospital
45d
Cleared
Apr 13, 2022
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Summit Glove, Inc.
General Hospital
63d
Cleared
Apr 13, 2022
Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
Summit Glove, Inc.
General Hospital
63d
Cleared
Apr 11, 2022
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Central Medicare Sdn Bhd
General Hospital
171d
Cleared
Apr 11, 2022
Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
Aamedix Glove Sdn Bhd
General Hospital
83d
Cleared
Apr 11, 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
Ksg Medicare Sdn. Bhd.
General Hospital
75d
Cleared
Apr 09, 2022
Nitrile Examination Gloves
Watchtower Ppe Supplies, Inc.
General Hospital
207d