FDA.reportPublic FDA data

510(k) K083305

Device
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
Applicant
Wrp Asia Pacific Sdn. Bhd.
510(k) number
K083305
Product code
LZC
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-18
Date received
2008-11-10
Regulation
880.6250
Classification name
Medical 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
KIRK PENNER
Address
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor MY 43900 43900

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZC#

510(k), Device, Applicant table
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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