S.M.P.U. LATEX EXAMINATION GLOVES— 510(k) K895438

Substantially Equivalent

P.T. Surya Milani Plastic Utama

FDA 510(k) clearance K895438 for S.M.P.U. LATEX EXAMINATION GLOVES, Substantially Equivalent on 1989-10-31. Applicant: P.T. Surya Milani Plastic Utama. Device class: 1.

Clearance details

Applicant
P.T. Surya Milani Plastic Utama
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck,, NY, US
Download summary PDFView on FDA.gov ↗

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