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
193–216 of 1181
Cleared Jun 16, 2022
TC Gloves
K221186
Thanh Cong Pharmaceutical and Trading Company Limited
General Hospital · 52d
Cleared Jun 16, 2022
1st Glove Blue Nitrile Examination Gloves Powder Free
K221226
Koove Iot Pvt. , Ltd.
General Hospital · 49d
Cleared Jun 07, 2022
Zoupure Nitrile Powder Free Examination glove
K220693
Thai Rayong Product Glove Zoupure Co., Ltd.
General Hospital · 90d
Cleared Jun 06, 2022
Powder Free Nitrile Gloves
K213448
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
K220672
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
K220541
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
K220547
O&M Halyard, Inc.
General Hospital · 97d
Cleared Jun 01, 2022
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
K220488
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.
General Hospital · 99d
Cleared May 31, 2022
Disposable Powder Free Polyethylene Examination Gloves
K212699
Mastermax Plastic (Huizhou), Ltd.
General Hospital · 279d
Cleared May 28, 2022
Blue Nitrile Examination Gloves Powder Free
K212584
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
K213141
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)
K220609
Encompass Industries Sdn. Bhd.
General Hospital · 86d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629
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)
K220249
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)
K211810
Pt. Shamrock Manufacturing Corpora
General Hospital · 346d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155
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)
K212408
Pt. Maja Agung Latexindo
General Hospital · 288d
Cleared May 18, 2022
Nitrile Powder Free Examination Gloves
K220211
Hebei Kangxida Medical Technology Development Co., Ltd.
General Hospital · 112d
Cleared May 13, 2022
Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220429
One Glove Industrial Sdn Bhd
General Hospital · 87d
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
K220118
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
Synguard Nitrile Exam Glove
K220442
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
K220250
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428
One Glove Industrial Sdn Bhd
General Hospital · 84d