510(k) K211601

Device
Powder Free Latex Examination Glove, Non-Sterile
Applicant
Wrp Asia Pacific Sdn. Bhd.
510(k) number
K211601
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-22
Date received
2021-05-24
Regulation
880.6250
Classification name
Latex 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
Siti Syamimie Atirah Binti Mat
Address
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang MY 43900 43900

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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