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510(k) K172525

Device
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
Applicant
Central Medicare Sdn. Bhd.
510(k) number
K172525
Product code
LZC  
Decision
Substantially Equivalent (SESE)
Decision date
2017-11-13
Date received
2017-08-21
Regulation
880.6250
Classification name
Patient Examination Glove, Specialty
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
Arivalagan Subramaniam
Address
Pt 2609-2620, Bt 8, Jalan Changkat Jong Teluk Intan MY 36000 36000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth2026-01-14
K243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.2025-02-24
K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.2022-08-30
K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.2022-08-27
K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn Bhd2022-05-26
K220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.2022-05-14
K220353Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsNiujian Technology Co., Ltd.2022-03-31
K213910Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsChangzhou Universal Medical Equipment Co., Ltd.2022-03-10
K213325Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsAnhui Xinyisheng Medical Technology Co.,Ltd2022-01-28
K213076AspenMed+Aspen Glove Sdn. Bhd.2021-12-20
K212639Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd.2021-12-08
K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugsJr Engineering & Medical Technologies (M) Sdn. Bhd.2021-12-06
K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove0 & M Halyard, Inc.2020-10-11
K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)Medline Industires, Inc.2020-09-18
K193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateEver Global (Vietnam) Enterprise Corp2020-06-04

Legacy Summary#

summary

FDA Review#

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