SURGICAL GLOVES— 510(k) K884495

Name: FDA 510(k) clearance K884495
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Sanko Chemical Industry Co., Ltd.

FDA 510(k) clearance K884495 for SURGICAL GLOVES, Substantially Equivalent on 1989-07-14. Applicant: Sanko Chemical Industry Co., Ltd.. Device class: 1.

Clearance details

Applicant: Sanko Chemical Industry Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1988-10-12
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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