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., O&M Halyard, Inc. and Hartalega NGC Sdn. Bhd..

36
Total
36
Cleared
203d
Avg days
2021
Since

List of Polymer Patient Examination Glove devices cleared through 510(k)

36 devices
1–24 of 36
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 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 Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172
O&M Halyard, Inc.
General Hospital · 261d
Cleared Jan 08, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K243818
Hartalega NGC Sdn. Bhd.
General Hospital · 27d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K242558
O&M Halyard, Inc.
General Hospital · 111d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K241909
O&M Halyard, Inc.
General Hospital · 88d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780
Cardinal Health200, LLC
General Hospital · 64d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
K231938
O&M Halyard, Inc.
General Hospital · 266d
Cleared Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
K232538
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 87d
Cleared May 17, 2023
Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
K223437
Hartalega NGC Sdn. Bhd.
General Hospital · 184d
Cleared Mar 25, 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
K220644
Yty Industry (Manjung) Sdn Bhd
General Hospital · 386d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
K222225
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 02, 2022
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K211816
Brightway Holdings Sdn. Bhd.
General Hospital · 509d
Cleared Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
K213937
O&M Halyard, Inc.
General Hospital · 243d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K213929
O&M Halyard, Inc.
General Hospital · 228d
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 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 Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
K212148
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 04, 2022
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
K210330
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 393d
Cleared Jan 28, 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
K213142
Shen Wei (Usa), Inc.
General Hospital · 123d
Cleared Nov 19, 2021
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063
O&M Halyard, Inc.
General Hospital · 224d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390
Cardinal Health200, LLC
General Hospital · 115d

How to use this database

This page lists all FDA 510(k) submissions for Polymer Patient Examination Glove devices (product code LZA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →