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Panels › General Hospital › Product code LZA · Class 1

Polymer Patient Examination Glove

Regulation 880.6250

16510(k)s in 12 months (1,181 all time)
3recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in LZA

Company510(k)sRecalls
Shen Wei (Usa), Inc.340
Hartalega Sdn Bhd330
Hartalega NGC Sdn. Bhd.240
Smart Glove Corp. Sdn Bhd190
Siam Sempermed Corp., Ltd.170
Yty Industry (Manjung) Sdn Bhd170
Gx Corporation Sdn Bhd150
Wrp Asia Pacific Sdn. Bhd.150
Eco Medi Glove Sdn. Bhd.140
O&M Halyard, Inc.140
Decided510(k)Device and applicantCode
Oct 1, 2026K262208Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemo
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Sep 9, 2026K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet
Top Glove Sdn. Bhd., MY
LZA
Sep 9, 2026K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color
Maxter Healthcare, Inc.
LZA
Sep 8, 2026K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance
Gmp Medicare Sdn. Bhd., MY
LZA
Sep 2, 2026K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Cardinalhealth
LZA
Aug 18, 2026K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHE
Kossan International Sdn Bhd, MY
LZA
Jul 21, 2026K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jul 20, 2026K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examinati
Hartalega NGC Sdn. Bhd., MY
LZA
Jun 24, 2026K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrat
Sw Technologies, Inc.
LZA
Jun 18, 2026K253824Powder Free Nitrile Examination Gloves Non-Sterile Black
Kanglongda Vietnam Protection Technology Company Limited, VN
LZA
Jun 17, 2026K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powde
Hartalega NGC Sdn. Bhd., MY
LZA
Jun 3, 2026K260806Nitrile Disposable Examination Gloves
Vista Industries,, LLC
LZA
Jun 3, 2026K260703Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitri
S&S Glove Corporation, VN
LZA
Jan 23, 2026K253160Syntex Exam Gloves
Basic Medical Technology, Inc.
LZA
Jan 13, 2026K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fen
Kossan International Sdn Bhd, MY
LZA
Nov 17, 2025K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fent
Mercator Medical (Thailand), Ltd., TH
LZA
Oct 23, 2025K250861Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid a
Hartalega NGC Sdn. Bhd., MY
LZA
Oct 17, 2025K252075Program insite® Powder-Free, Disposable Nitrile Exam Gloves
Program Insite, LLC
LZA
Aug 27, 2025K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid
Basic Medical Technology, Inc.
LZA
Aug 21, 2025K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate,
Ever Global (Vietnam) Enterprise Corporation, VN
LZA
Aug 18, 2025K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs,
O&M Halyard, Inc.
LZA
Jul 30, 2025K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Steril
Hartalega NGC Sdn. Bhd., MY
LZA
Jul 9, 2025K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric
Basic Medical Technology, Inc.
LZA
Jul 8, 2025K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Encompass Industries Sdn. Bhd., MY
LZA
Jul 7, 2025K250496Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
Zibo Shengkun Chemical Industry Co., Ltd., CN
LZA
Jun 18, 2025K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile
O&M Halyard, Inc.
LZA
Jun 17, 2025K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl C
Kl-Kepong Rubber Products Sdn. Bhd., MY
LZA
Jun 6, 2025K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fenta
Mah Sing Healthcare Sdn. Bhd., MY
LZA
Jun 3, 2025K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Glove One, LLC
LZA
May 22, 2025K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrat
Basic Medical Technology, Inc.
LZA
Apr 23, 2025K250944Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentan
Gmp Medicare Sdn. Bhd., MY
LZA
Apr 1, 2025K250578Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Careglove Global Sdn. Bhd., MY
LZA
Mar 19, 2025K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
Safesource Direct, LLC
LZA
Mar 18, 2025K242533Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with
Better Care Plastic Technology Co., Ltd., CN
LZA
Feb 18, 2025K243792Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Basic Medical Technology, Inc.
LZA
Feb 6, 2025K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat
Ever Global (Vietnam) Enterprise Corporation, VN
LZA
Jan 31, 2025K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid
Basic Medical Technology, Inc.
LZA
Jan 15, 2025K242936Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Sunray Medical Products, Inc.
LZA
Jan 8, 2025K243818Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd., MY
LZA
Dec 17, 2024K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fen
O&M Halyard, Inc.
LZA
Oct 25, 2024K240269Nitrile Powder Free Examination Gloves Biodegradable (Green)
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Oct 12, 2024K242812NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Nb Medical Company Limited, VN
LZA
Sep 27, 2024K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta
O&M Halyard, Inc.
LZA
Sep 11, 2024K241745Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citra
Ksg Medicare Sdn. Bhd., MY
LZA
Aug 28, 2024K240545GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/X
Genabio Diagnostics, Inc.
LZA
Aug 23, 2024K241780Cardinal Health Nitrile Exam Gloves
Cardinal Health200, LLC
LZA
Aug 6, 2024K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Aug 2, 2024K241970Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,
Kanglongda Vietnam Protection Technology Company Limited, VN
LZA
Jul 2, 2024K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue;
Sri Trang Gloves Thailand (Public Company Limited), TH
LZA
Jun 25, 2024K240824Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005)
Ningxia Qiaoen Medical Technology Co., Ltd., CN
LZA

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