FDA.reportPublic FDA data

510(k) K212833

Device
Disposable Nitrile Examination Gloves
Applicant
Chifeng Huawei Medical Science&Technology Co., Ltd.
510(k) number
K212833
Product code
LZA
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-28
Date received
2021-09-07
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Li Xiaohong
Address
# 2-4, Second-Stage Standardized Plant, Songshan (Anqing) Industrial Park Chifeng CN 024023 024023

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260806Nitrile Disposable Examination GlovesVista Industries,, LLC2026-06-03
K260703Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and FentanylS&S Glove Corporation2026-06-03
K253160Syntex Exam GlovesBasic Medical Technology, Inc.2026-01-23
K252549Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric AcidKossan International Sdn Bhd2026-01-13
K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl CitrateMercator Medical (Thailand), Ltd.2025-11-17
K250861Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)Hartalega NGC Sdn. Bhd.2025-10-23
K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC2025-10-17
K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl CitrateBasic Medical Technology, Inc.2025-08-27
K252244Disposable 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 acidEver Global (Vietnam) Enterprise Corporation2025-08-21
K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric AcidO&M Halyard, Inc.2025-08-18
K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended CuffHartalega NGC Sdn. Bhd.2025-07-30
K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)Basic Medical Technology, Inc.2025-07-09
K250342Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and FentanylEncompass Industries Sdn. Bhd.2025-07-08
K250496Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)Zibo Shengkun Chemical Industry Co., Ltd.2025-07-07
K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile SinglesO&M Halyard, Inc.2025-06-18