PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K891258

Substantially Equivalent

Aek Rubber Product Sdn. Bhd.

FDA 510(k) clearance K891258 for PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-04-25. Applicant: Aek Rubber Product Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Aek Rubber Product 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
Ehsan, Malaysia, MY
Download summary PDFView on FDA.gov ↗

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