NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED— 510(k) K051563

Substantially Equivalent

Terang Nusa Sdn Bhd

FDA 510(k) clearance K051563 for NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED, Substantially Equivalent on 2005-06-20. Applicant: Terang Nusa Sdn Bhd. Device class: 1.

Clearance details

Applicant
Terang Nusa Sdn Bhd
Product code
Code KGO
Device class
Class 1
Regulation
21 CFR 878.4460
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Kota Bharu, Kelantan, MY
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