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 Basic Medical Technology, Inc..

1168
Total
1168
Cleared
117d
Avg days
1984
Since
1168 devices
73–96 of 1168
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 May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
K230121
Careglove Global Sdn. Bhd.
General Hospital · 118d
Cleared Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
K221983
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 295d
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
Cleared Aug 11, 2021
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
K202536
Yty Industry (Manjung) Sdn Bhd
General Hospital · 344d
Cleared Jul 28, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K211455
Shen Wei (Usa), Inc.
General Hospital · 79d
Cleared Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
K202085
Shen Wei (Usa), Inc.
General Hospital · 329d
Cleared Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K210401
Ansell Healthcare Products, LLC
General Hospital · 123d
Cleared Mar 25, 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K202083
Shen Wei (Usa), Inc.
General Hospital · 241d
Cleared Mar 24, 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
K202080
Shen Wei (Usa), Inc.
General Hospital · 240d
Cleared Mar 19, 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
K202081
Shen Wei (Usa), Inc.
General Hospital · 235d
Cleared Mar 17, 2021
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
K202082
Shen Wei (Usa), Inc.
General Hospital · 233d