PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K892074

Substantially Equivalent

Perusahaan Intan Emas Sdn. Bhd.

FDA 510(k) clearance K892074 for PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-04-28. Applicant: Perusahaan Intan Emas Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Perusahaan Intan Emas Sdn. Bhd.
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
Beranang, Selangor, D.E., MY
Download summary PDFView on FDA.gov ↗

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