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
97–120 of 1181
Cleared Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223713
Better Care Plastic Technology Co., Ltd.
General Hospital · 238d
Cleared Jul 24, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
K223752
Central Medicare Sdn Bhd
General Hospital · 221d
Cleared Jul 21, 2023
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K231021
Kimberly Clark Corporation
General Hospital · 102d
Cleared Jul 20, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
K230875
Central Medicare Sdn Bhd
General Hospital · 112d
Cleared Jul 04, 2023
MemorialTM Gloves
K231740
Us Glove Supply
General Hospital · 20d
Cleared Jun 09, 2023
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K230779
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 80d
Cleared Jun 06, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
K231349
Nephron Nitrile, LLC
General Hospital · 28d
Cleared Jun 05, 2023
APOLLO ADVANTAGE Nitrile Examination Gloves
K230633
Dell Corning Corporation
General Hospital · 90d
Cleared May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542
Huizhou Anboson Technology Co., Ltd.
General Hospital · 92d
Cleared May 30, 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958
First Glove Sdn. Bhd.
General Hospital · 56d
Cleared May 28, 2023
Blue Nitrile Examination Gloves Powder Free
K230601
Latrile Gloves Private Limited
General Hospital · 86d
Cleared May 23, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves
K230564
Central Medicare Sdn Bhd
General Hospital · 83d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
K223437
Hartalega NGC Sdn. Bhd.
General Hospital · 184d
Cleared May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K230121
Careglove Global Sdn. Bhd.
General Hospital · 118d
Cleared May 08, 2023
Disposible Nitrile Gloves
K223280
Holik Asia Group Co.,Ltd
General Hospital · 196d
Cleared Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
K221983
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 295d
Cleared Mar 30, 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K220088
Professional Latex Sdn Bhd
General Hospital · 443d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
K220644
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
K230002
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 23, 2023
Disposable Medical Nitrile Examination Gloves
K223895
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital · 85d
Cleared Mar 16, 2023
Nitrile Examination Gloves
K222813
Ecoglove Medical Manufacturing Company Limited
General Hospital · 178d
Cleared Mar 15, 2023
Tegamen Nitrile Examination Gloves
K223102
M/S Tegamen Safety Products Private Limited
General Hospital · 166d
Cleared Mar 15, 2023
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
K223375
Kossan International Sdn Bhd3
General Hospital · 131d
Cleared Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
K223859
Rhino Health, Inc.
General Hospital · 52d