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 Medline Industries, Inc., O&M Halyard, Inc. and Shen Wei (Usa), Inc..

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
97–120 of 1170
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
Cleared Feb 10, 2023
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K222129
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 207d
Cleared Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
K223559
Nephron Pharmaceuticals Corporation
General Hospital · 73d
Cleared Feb 06, 2023
Powder Free Blue Nitrile Examination Glove
K223444
S&S Glove Corporation
General Hospital · 84d
Cleared Jan 27, 2023
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102)
K223903
Semperit Investments Asia Pte , Ltd.
General Hospital · 30d
Cleared Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223415
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 77d
Cleared Jan 22, 2023
Synthetic Polymer Glove - Polyethylene (Black)
K222531
Ur Industry Sdn Bhd
General Hospital · 153d
Cleared Jan 19, 2023
Disposable Nitrile Examination Glove
K223250
Yangzhou Saraguard Medical Supplies Co., Ltd.
General Hospital · 90d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221
Dynacare Sdn Bhd
General Hospital · 88d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 11, 2023
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
K222181
Iconic Medicare Sdn Bhd
General Hospital · 173d
Cleared Jan 04, 2023
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K222907
Rmkh Glove (Cambodia) Co., Ltd.
General Hospital · 100d