POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1— 510(k) K101103

Name: FDA 510(k) clearance K101103
Creator: U.S. Food and Drug Administration
Published: 2010-07-16

Substantially Equivalent

Best Putra Gloves Sdn Bhd

FDA 510(k) clearance K101103 for POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1, Substantially Equivalent on 2010-07-16. Applicant: Best Putra Gloves Sdn Bhd. Device class: 1.

Clearance details

Applicant: Best Putra Gloves Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2010-04-20
Decision date: 2010-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sg Choh Rawang, Selangor, MY

Download summary PDF View on FDA.gov ↗

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