Hi Coat Powder Free Latex Patient Examination Gloves— 510(k) K972539

Substantially Equivalent

P.T. Latexindo Tobaperkasa

FDA 510(k) clearance K972539 for Hi Coat Powder Free Latex Patient Examination Gloves, Substantially Equivalent on 1997-11-18. Applicant: P.T. Latexindo Tobaperkasa. Device class: 1.

Clearance details

Applicant
P.T. Latexindo Tobaperkasa
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
Medan, ID
Download summary PDFView on FDA.gov ↗

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