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
217–240 of 1181
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
Cleared Apr 09, 2022
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
K220401
Riverstone Resources Sdn Bhd
General Hospital · 57d
Cleared Apr 03, 2022
ELAZ Nitrile Powder Free Examination Glove
K213604
Protect Gloves Co., Ltd.
General Hospital · 139d
Cleared Apr 03, 2022
Medical Nitrile Examination Gloves
K220066
Hunan Zhenheyikang Medical Instrument Co., Ltd.
General Hospital · 83d
Cleared Apr 02, 2022
Nitrile Examination Gloves
K220343
Nb Medical Co., Ltd.
General Hospital · 54d
Cleared Mar 31, 2022
Nitrile Examination Gloves
K213843
Dong Tai City Huayi Gloves Co., Ltd.
General Hospital · 112d
Cleared Mar 28, 2022
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
K213662
Taishan Weibang Medical Equipment Co., Ltd.
General Hospital · 126d
Cleared Mar 26, 2022
Clover Glove
K213729
Clover Glove Company Limited
General Hospital · 120d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
K220215
Ksg Medicare Sdn. Bhd.
General Hospital · 59d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Gloves, Orange
K220229
Shanxi Hongjin Plastic Technology Co., Ltd.
General Hospital · 58d
Cleared Mar 25, 2022
Medical nitrile examination gloves (Model: JL001)
K213848
Guangdong Jiali Pharmaceutical Co.,Ltd
General Hospital · 105d
Cleared Mar 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K212916
Rimba Glove Sdn Bhd
General Hospital · 192d
Cleared Mar 24, 2022
Disposable Medical Synthetic Nitrile Examination Gloves
K220354
Niujian Technology Co., Ltd.
General Hospital · 44d
Cleared Mar 22, 2022
Powder Free Blue Nitrile Examination Gloves
K213678
Lienteh Technology Sdn Bhd
General Hospital · 120d