FDA.report

510(k) K953213

Device
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
Applicant
WEMBLEY RUBBER PRODUCTS (M) SDN BHD
510(k) number
K953213
Product code
LYY  
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-11
Date received
1995-07-10
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ONG G CHEE
Address
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, Sepang Selangor MY 43900 43900

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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