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
Jun 16, 2022
TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited
General Hospital
52d
Cleared
Jun 16, 2022
1st Glove Blue Nitrile Examination Gloves Powder Free
Koove Iot Pvt. , Ltd.
General Hospital
49d
Cleared
Jun 07, 2022
Zoupure Nitrile Powder Free Examination glove
Thai Rayong Product Glove Zoupure Co., Ltd.
General Hospital
90d
Cleared
Jun 06, 2022
Powder Free Nitrile Gloves
St Future International Limited
General Hospital
224d
Cleared
Jun 03, 2022
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Riverstone Resources Sdn Bhd
General Hospital
88d
Cleared
Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
General Hospital
97d
Cleared
Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
General Hospital
97d
Cleared
Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.
General Hospital
99d
Cleared
May 31, 2022
Disposable Powder Free Polyethylene Examination Gloves
Mastermax Plastic (Huizhou), Ltd.
General Hospital
279d
Cleared
May 28, 2022
Blue Nitrile Examination Gloves Powder Free
Amazing Rubber Products Pvt, Ltd.
General Hospital
285d
Cleared
May 28, 2022
Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Shen Wei (Usa), Inc.
General Hospital
243d
Cleared
May 27, 2022
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Encompass Industries Sdn. Bhd.
General Hospital
86d
Cleared
May 26, 2022
PP Care Nitrile Examination Gloves
Eg Group Product and Services Co., Ltd.
General Hospital
280d
Cleared
May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Grand Work Plastic Products Co., Ltd.
General Hospital
115d
Cleared
May 23, 2022
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Pt. Shamrock Manufacturing Corpora
General Hospital
346d
Cleared
May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Motex Healthcare (Anhui) Co., Ltd.
General Hospital
124d
Cleared
May 18, 2022
Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Pt. Maja Agung Latexindo
General Hospital
288d
Cleared
May 18, 2022
Nitrile Powder Free Examination Gloves
Hebei Kangxida Medical Technology Development Co., Ltd.
General Hospital
112d
Cleared
May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd
General Hospital
87d
Cleared
May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital
118d
Cleared
May 12, 2022
Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment Co., Ltd.
General Hospital
85d
Cleared
May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd.
General Hospital
100d
Cleared
May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd
General Hospital
84d
Cleared
May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd
General Hospital
84d