Sterile Latex Surgical Gloves Powder Free— 510(k) K211478

Substantially Equivalent

Aspen Glove Sdn. Bhd.

FDA 510(k) clearance K211478 for Sterile Latex Surgical Gloves Powder Free, Substantially Equivalent on 2021-09-16. Applicant: Aspen Glove Sdn. Bhd..

Clearance details

Applicant: Aspen Glove Sdn. Bhd.
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2021-05-12
Decision date: 2021-09-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Georgetown, MY

Download summary PDF View on FDA.gov ↗

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