Sterile Nitrile Surgical Gloves, Powder-free— 510(k) K170515

Name: FDA 510(k) clearance K170515
Creator: U.S. Food and Drug Administration
Published: 2017-06-09

Substantially Equivalent

Primus Gloves Pvt Limited

FDA 510(k) clearance K170515 for Sterile Nitrile Surgical Gloves, Powder-free, Substantially Equivalent on 2017-06-09. Applicant: Primus Gloves Pvt Limited. Device class: 1.

Clearance details

Applicant: Primus Gloves Pvt Limited
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2017-02-21
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cochin, IN

Download summary PDF View on FDA.gov ↗

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