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
457–480 of 1181
Cleared Sep 16, 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
K191800
Kossan International Sdn Bhd
General Hospital · 75d
Cleared Sep 06, 2019
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
K190403
Ever Global (Vietnam) Enterprise Corporation
General Hospital · 199d
Cleared Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
K182089
Platinum Glove Industries Sdn. Bhd.
General Hospital · 362d
Cleared Jul 26, 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
K183280
Smart Glove Corporation Sdn. Bhd.
General Hospital · 245d
Cleared Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
K190080
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 162d
Cleared Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K182851
O&M Halyard, Inc.
General Hospital · 259d
Cleared Jun 20, 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
K183354
Gx Corporation Sdn Bhd
General Hospital · 199d
Cleared May 30, 2019
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
K182308
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 279d
Cleared May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K190606
Kossan International Sdn Bhd
General Hospital · 81d
Cleared May 10, 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
K182612
Zibo Yahao Supplies Co., Ltd.
General Hospital · 231d
Cleared Apr 12, 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
K182640
Shandong Hengya Packaging Printing Co.,Ltd
General Hospital · 200d
Cleared Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K183287
Kossan International Sdn Bhd
General Hospital · 130d
Cleared Mar 22, 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
K182554
He Chuang Plastic & Rubber Co., Ltd.
General Hospital · 186d
Cleared Mar 11, 2019
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
K182241
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital · 203d
Cleared Jan 16, 2019
Powder Free Nitrile Patient Examination Gloves, Blue Color
K181106
Jiangsu Dongxin Medical Technology Co., Ltd.
General Hospital · 265d
Cleared Dec 21, 2018
Nitrile Glove Powder Free White
K183068
Haining Medical Products Co., Ltd.
General Hospital · 46d
Cleared Nov 30, 2018
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
K182600
Better Care Plastic Technology Co., Ltd.
General Hospital · 70d
Cleared Nov 20, 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K181857
Kossan International Sdn Bhd
General Hospital · 132d
Cleared Nov 16, 2018
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
K180645
Hartalega Sdn Bhd
General Hospital · 249d
Cleared Nov 15, 2018
Nitrile Glove Powder Free Black
K182528
Haining Medical Products Co., Ltd.
General Hospital · 62d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
K180786
Hartalega Sdn Bhd
General Hospital · 221d
Cleared Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
K182096
Owens & Minor Halyard, Inc.
General Hospital · 91d
Cleared Oct 10, 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467
Showa Best Glove, Inc.
General Hospital · 231d
Cleared Oct 10, 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468
Showa Best Glove, Inc.
General Hospital · 231d