STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING— 510(k) K031670

Name: FDA 510(k) clearance K031670
Creator: U.S. Food and Drug Administration
Published: 2003-09-23

Substantially Equivalent

P.T. Saptindo Surgica

FDA 510(k) clearance K031670 for STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING, Substantially Equivalent on 2003-09-23. Applicant: P.T. Saptindo Surgica. Device class: 1.

Clearance details

Applicant: P.T. Saptindo Surgica
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2003-05-29
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Serang-Banten, ID

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.