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
Cleared
Mar 16, 2021
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
Shen Wei (Usa), Inc.
General Hospital
232d
Cleared
Mar 05, 2021
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Mar 05, 2021
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei (Usa), Inc.
General Hospital
221d
Cleared
Mar 02, 2021
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Kanglongda Vietnam Protection Technology Company Limited
General Hospital
195d
Cleared
Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
Jiangsu Tianshuo Medical Products Co., Ltd.
General Hospital
192d
Cleared
Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Gmp Medicare Sdn. Bhd.
General Hospital
219d
Cleared
Feb 12, 2021
LYDUS Nitrile Examination Gloves, Powder Free
Nathan Trading Co., Ltd.
General Hospital
108d
Cleared
Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
O&M Halyard, Inc.
General Hospital
119d
Cleared
Dec 02, 2020
Palm Care Blue Nitrile Examination Gloves Powder Free
Hi-Care Thai Gloves Co. , Ltd.
General Hospital
104d
Cleared
Nov 30, 2020
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Kimberly Clark Corporation
General Hospital
98d
Cleared
Oct 26, 2020
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
Medline Industries, Inc.
General Hospital
278d
Cleared
Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
O&M Halyard, Inc.
General Hospital
175d
Cleared
Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
Top Glove Sdn. Bhd.
General Hospital
395d
Cleared
Aug 25, 2020
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd.
General Hospital
57d
Cleared
Aug 20, 2020
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
Anhui Lntco Medical Products Co., Ltd.
General Hospital
217d
Cleared
Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Hartalega NGC Sdn. Bhd.
General Hospital
58d
Cleared
Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega Sdn Bhd
General Hospital
58d
Cleared
Aug 04, 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff
Medline Industries, Inc.
General Hospital
217d
Cleared
Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
Medline Industires, Inc.
General Hospital
94d
Cleared
Jun 19, 2020
Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital
242d
Cleared
Jun 19, 2020
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
Ansell Healthcare Products, LLC
General Hospital
98d
Cleared
Jun 06, 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
Mercator Medical (Thailand), Ltd.
General Hospital
57d
Cleared
Jun 05, 2020
Latex Examination Powder Free Glove, Aloe Vera
Top Glove Sdn. Bhd.
General Hospital
205d
Cleared
May 01, 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
Yty Industry (Manjung) Sdn Bhd
General Hospital
67d