Medical Device Manufacturer · MY , Bestari Jaya

Hartalega Snd. Bhd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2012

Recent clearances: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs, NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hartalega Snd. Bhd. General Hospital ✕

2 devices

1-2 of 2

Cleared Oct 13, 2016

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...

General Hospital · 227d

Cleared Feb 02, 2012

NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM

General Hospital · 119d