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
433–456 of 1181
Cleared Apr 25, 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K200581
Hartalega NGC Sdn. Bhd.
General Hospital · 51d
Cleared Apr 15, 2020
Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K200181
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 82d
Cleared Apr 10, 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
K200072
Kimberly Clark Corporation
General Hospital · 87d
Cleared Apr 09, 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Apr 09, 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
K200539
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 37d
Cleared Apr 06, 2020
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
K200019
Hartalega NGC Sdn. Bhd.
General Hospital · 94d
Cleared Mar 20, 2020
GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
K193121
Eco Medi Glove Sdn. Bhd.
General Hospital · 129d
Cleared Mar 20, 2020
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
K193581
Sri Trang Gloves (Thailand) Public Company Limited
General Hospital · 88d
Cleared Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
K191753
Medline Industries, Inc.
General Hospital · 260d
Cleared Mar 13, 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K192241
O&M Haylard, Inc.
General Hospital · 207d
Cleared Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
K192333
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital · 150d
Cleared Jan 17, 2020
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
K192635
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 116d
Cleared Jan 10, 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K192315
Medline Industries, Inc.
General Hospital · 137d
Cleared Jan 07, 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
K190942
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 272d
Cleared Dec 31, 2019
mCare® Powder Free Nitrile Black Examination Glove
K192444
Mercator Medical (Thailand), Ltd.
General Hospital · 116d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
K190736
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 277d
Cleared Dec 23, 2019
Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
K190860
Ever Growth (Vietnam) Co. , Ltd.
General Hospital · 265d
Cleared Dec 23, 2019
Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
K192104
Medline Industries, Inc.
General Hospital · 140d
Cleared Dec 17, 2019
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
K190725
Riverstone Resources Sdn Bhd
General Hospital · 272d
Cleared Dec 02, 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
K190876
Mercator Medical (Thailand), Ltd.
General Hospital · 242d
Cleared Nov 08, 2019
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
K192232
Hartalega NGC Sdn. Bhd.
General Hospital · 84d
Cleared Oct 04, 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K183441
Semperit Investments Asia Pte , Ltd.
General Hospital · 296d
Cleared Sep 26, 2019
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
K190454
Hartalega NGC Sdn. Bhd.
General Hospital · 213d
Cleared Sep 26, 2019
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate
K190466
Shen Wei (Usa), Inc.
General Hospital · 212d