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
Declining activity - 41 submissions in the last 2 years vs 114 in the prior period
Consistent review times: 134d avg (recent)

FDA 510(k) Cleared Polymer Patient Examination Glove Devices (Product Code LZA)

1181 devices
1–24 of 1181
Cleared Oct 01, 2026
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
K262208
Yty Industry (Manjung) Sdn Bhd
General Hospital · 93d
Cleared Sep 09, 2026
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
K261793
Maxter Healthcare, Inc.
General Hospital · 103d
Cleared Sep 09, 2026
Biodegradable Nitrile Powder Free Examination Glove, Green
K262542
Top Glove Sdn. Bhd.
General Hospital · 48d
Cleared Sep 08, 2026
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K260312
Gmp Medicare Sdn. Bhd.
General Hospital · 221d
Cleared Sep 02, 2026
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K261749
Cardinalhealth
General Hospital · 97d
Cleared Aug 18, 2026
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
K260794
Kossan International Sdn Bhd
General Hospital · 160d
Cleared Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014
O&M Halyard, Inc.
General Hospital · 36d
Cleared Jul 20, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue
K254285
Hartalega NGC Sdn. Bhd.
General Hospital · 201d
Cleared Jun 24, 2026
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
K252117
Sw Technologies, Inc.
General Hospital · 352d
Cleared Jun 18, 2026
Powder Free Nitrile Examination Gloves Non-Sterile Black
K253824
Kanglongda Vietnam Protection Technology Company Limited
General Hospital · 199d
Cleared Jun 17, 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K260867
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jun 03, 2026
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
K260703
S&S Glove Corporation
General Hospital · 91d
Cleared Jun 03, 2026
Nitrile Disposable Examination Gloves
K260806
Vista Industries,, LLC
General Hospital · 83d
Cleared Jan 23, 2026
Syntex Exam Gloves
K253160
Basic Medical Technology, Inc.
General Hospital · 119d
Cleared Jan 13, 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
K252549
Kossan International Sdn Bhd
General Hospital · 153d
Cleared Nov 17, 2025
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K251141
Mercator Medical (Thailand), Ltd.
General Hospital · 217d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
K250861
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 17, 2025
Program insite® Powder-Free, Disposable Nitrile Exam Gloves
K252075
Program Insite, LLC
General Hospital · 107d
Cleared Aug 27, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
K251716
Basic Medical Technology, Inc.
General Hospital · 84d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
K252244
Ever Global (Vietnam) Enterprise Corporation
General Hospital · 34d
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
K243604
O&M Halyard, Inc.
General Hospital · 270d
Cleared Jul 30, 2025
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K251319
Hartalega NGC Sdn. Bhd.
General Hospital · 92d
Cleared Jul 09, 2025
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
K250193
Basic Medical Technology, Inc.
General Hospital · 167d
Cleared Jul 08, 2025
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
K250342
Encompass Industries Sdn. Bhd.
General Hospital · 152d

About Product Code LZA - Regulatory Context

510(k) Submission Activity

1181 total 510(k) submissions under product code LZA since 1984, with 1181 receiving FDA clearance (average review time: 118 days).

Submission volume has declined in recent years - 41 submissions in the last 24 months compared to 114 in the prior period.

FDA 510(k) Review Time - LZA Product Code

FDA review times for LZA submissions have been consistent, averaging 134 days recently vs 117 days historically.

LZA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →