NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs— 510(k) K150973

Name: FDA 510(k) clearance K150973
Creator: U.S. Food and Drug Administration
Published: 2015-08-04

Substantially Equivalent

Terang Nusa Snd Bhd

FDA 510(k) clearance K150973 for NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2015-08-04. Applicant: Terang Nusa Snd Bhd. Device class: 1.

Clearance details

Applicant: Terang Nusa Snd Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2015-04-13
Decision date: 2015-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kota Bharu, MY

Download summary PDF View on FDA.gov ↗

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