
Biofilm, Inc.
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Astroglide Diamond Silicone Gel Personal Lubricant is an FDA 510(k)-cleared medical device (K163395) manufactured by Biofilm, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2017. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031