FDA.report

510(k) K250578

Device
Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
Applicant
Careglove Global Sdn. Bhd.
510(k) number
K250578
Product code
LZA
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-01
Date received
2025-02-27
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Lim Kwee Shyan
Address
Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Indsutrial Estate Seremban MY 70450 70450

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code LZA

510(k)DeviceApplicantDecision date
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
K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric AcidKl-Kepong Rubber Products Sdn. Bhd.2025-06-17
K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - BlueMah Sing Healthcare Sdn. Bhd.2025-06-06