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

1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
169–192 of 1170
Cleared Jul 27, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K221271
Shandong Maida Medical Technology Co., Ltd.
General Hospital · 86d
Cleared Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877
Goodgloves Industries Sdn Bhd
General Hospital · 25d
Cleared Jul 19, 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
K220943
Eco Medi Glove Sdn. Bhd.
General Hospital · 110d
Cleared Jul 16, 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
K221229
Zibo Blue Sail Health Technology Co., Ltd.
General Hospital · 78d
Cleared Jul 12, 2022
Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
K213574
Grand Work Plastic Products Co., Ltd.
General Hospital · 244d
Cleared Jul 12, 2022
Nitrile Medical Examination Gloves
K221108
Anhui Fulewei Electronic Technology Co.,Ltd
General Hospital · 88d
Cleared Jul 12, 2022
Disposable Medical Nitrile Examination Gloves - Non Sterile
K221454
Guangzhou Kangling Biotechnology Co., Ltd.
General Hospital · 54d
Cleared Jul 08, 2022
Powder Free Nitrile Examination Gloves (Blue)
K220284
Kgm Gloves Sdn. Bhd.
General Hospital · 157d
Cleared Jul 08, 2022
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
K220825
American Nitrile Operations, LLC
General Hospital · 109d
Cleared Jun 29, 2022
Powder Free Nitrile Examination Glove
K220834
Daxwell, LLC
General Hospital · 99d
Cleared Jun 22, 2022
Nitrile Examination Gloves
K213739
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 205d
Cleared Jun 22, 2022
Disposable Nitrile Powder-Free Examination Gloves
K221192
Shandong Maida Medical Technology Co., Ltd.
General Hospital · 58d
Cleared Jun 17, 2022
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220431
One Glove Industrial Sdn Bhd
General Hospital · 122d
Cleared Jun 16, 2022
TC Gloves
K221186
Thanh Cong Pharmaceutical and Trading Company Limited
General Hospital · 52d
Cleared Jun 16, 2022
1st Glove Blue Nitrile Examination Gloves Powder Free
K221226
Koove Iot Pvt. , Ltd.
General Hospital · 49d
Cleared Jun 07, 2022
Zoupure Nitrile Powder Free Examination glove
K220693
Thai Rayong Product Glove Zoupure Co., Ltd.
General Hospital · 90d
Cleared Jun 06, 2022
Powder Free Nitrile Gloves
K213448
St Future International Limited
General Hospital · 224d
Cleared Jun 03, 2022
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
K220672
Riverstone Resources Sdn Bhd
General Hospital · 88d
Cleared Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
K220541
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
K220547
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.
General Hospital · 99d
Cleared May 31, 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699
Mastermax Plastic (Huizhou), Ltd.
General Hospital · 279d
Cleared May 28, 2022
Blue Nitrile Examination Gloves Powder Free
K212584
Amazing Rubber Products Pvt, Ltd.
General Hospital · 285d
Cleared May 28, 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
K213141
Shen Wei (Usa), Inc.
General Hospital · 243d