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
193–216 of 1170
Cleared May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
K220609
Encompass Industries Sdn. Bhd.
General Hospital · 86d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629
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)
K220249
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)
K211810
Pt. Shamrock Manufacturing Corpora
General Hospital · 346d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155
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)
K212408
Pt. Maja Agung Latexindo
General Hospital · 288d
Cleared May 18, 2022
Nitrile Powder Free Examination Gloves
K220211
Hebei Kangxida Medical Technology Development Co., Ltd.
General Hospital · 112d
Cleared May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220429
One Glove Industrial Sdn Bhd
General Hospital · 87d
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
K220118
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
Synguard Nitrile Exam Glove
K220442
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
K220250
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428
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
K213040
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 217d
Cleared Apr 21, 2022
Ivory Glove Powder-Free Nitrile Examination Gloves
K213681
Ivory Gloves Sdn. Bhd.
General Hospital · 150d
Cleared Apr 21, 2022
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
K220382
Jiangsu Bytech Medical Supplies Co., Ltd.
General Hospital · 70d
Cleared Apr 17, 2022
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
K213408
Meditech Gloves Sdn Bhd
General Hospital · 180d
Cleared Apr 14, 2022
Disposable Medical Nitrile Examination Gloves
K220561
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)
K220373
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)
K220375
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
K213437
Central Medicare Sdn Bhd
General Hospital · 171d
Cleared Apr 11, 2022
Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
K220121
Aamedix Glove Sdn Bhd
General Hospital · 83d
Cleared Apr 11, 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
K220209
Ksg Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Apr 09, 2022
Nitrile Examination Gloves
K212929
Watchtower Ppe Supplies, Inc.
General Hospital · 207d