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..
1175
Total
1175
Cleared
118d
Avg days
1984
Since
1175 devices
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
O&M Haylard, Inc.
General Hospital
207d
Cleared
Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
150d
Cleared
Jan 17, 2020
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
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)
Medline Industries, Inc.
General Hospital
137d
Cleared
Jan 07, 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
Ever Growth (Vietnam) Co. , Ltd.
General Hospital
272d
Cleared
Dec 31, 2019
mCare® Powder Free Nitrile Black Examination Glove
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
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
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)
Medline Industries, Inc.
General Hospital
140d
Cleared
Dec 17, 2019
Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Riverstone Resources Sdn Bhd
General Hospital
272d
Cleared
Dec 02, 2019
mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
Mercator Medical (Thailand), Ltd.
General Hospital
242d
Cleared
Nov 08, 2019
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
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
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
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
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
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
Ever Global (Vietnam) Enterprise Corporation
General Hospital
199d
Cleared
Jul 30, 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
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
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)
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
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
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
Sri Trang Gloves (Thailand) Co., Ltd.
General Hospital
279d
Cleared
May 28, 2019
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn Bhd
General Hospital
81d