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
433–456 of 1170
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
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