FDA.reportPublic FDA data

510(k) K212827

Device
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Applicant
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
510(k) number
K212827
Product code
LZC
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-06
Date received
2021-09-03
Regulation
880.6250
Classification name
Medical Glove, Specialty
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ganesan Subramaniam
Address
Lot 8 & 10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3a/1, Pusat Perindustrian 2 Hulu Selangor MY 44200 44200

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
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
K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam GlovesO&M Halyard, Inc.2019-11-08