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SancDam Latex Oral Dam

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212037

by Sanctuary Health Sdn Bhd

Identifiers

510(k) Number
K212037 FDA 510(k)
FDA Product Code
MSC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SancDam Latex Oral Dam is a Barrier, Standard, for Oral Sex, classified as a Class II medical device. It functions as a protective barrier during oral-genital contact to reduce the risk of transmission of sexually transmitted infections and unintended pregnancy, adhering to the definition of a latex-based barrier device.

This device is supplied as a single-use, non-sterile product and is intended for use in obstetrics and gynecology settings. It is manufactured in sizes corresponding to standard oral dam dimensions and must be stored in a clean, dry environment away from direct sunlight. The SancDam Latex Oral Dam holds FDA 510(k) clearance and MDR compliance, with a K-number of K212037 and product code MSC under the OpenFDA classification.

Frequently asked questions

What is the primary purpose of the SancDam Latex Oral Dam and in which clinical settings is it intended for use?

The SancDam Latex Oral Dam is designed as a protective barrier to reduce the risk of sexually transmitted infections and unintended pregnancy during oral-genital contact. It is specifically intended for use in obstetrics and gynecology settings, though it may also be applicable in other clinical environments where such protection is required.

Is the SancDam Latex Oral Dam sterile, and how should it be stored?

The SancDam Latex Oral Dam is supplied as a non-sterile product, meaning it is not intended for sterile procedures. To maintain its integrity, it should be stored in a clean, dry environment away from direct sunlight, as exposure to moisture or light could degrade its material properties.

Are these oral dams single-use or reusable, and what sizes are available?

The SancDam Latex Oral Dam is explicitly designed for single-use only, ensuring hygiene and safety per its intended purpose. While the exact dimensions are not detailed, it follows standard oral dam sizes, which typically range between 7–10 inches in length and 4–6 inches in width, though precise measurements should be confirmed with the manufacturer.

What regulatory pathways has the SancDam Latex Oral Dam followed, and what does this mean for its use?

The SancDam Latex Oral Dam holds FDA 510(k) clearance (K212037) and MDR compliance, confirming it meets U.S. and EU regulatory standards for Class II medical devices. This clearance indicates it is considered substantially equivalent to a predicate device, ensuring its safety and effectiveness for its intended use as a barrier during oral-genital contact. The product code MSC under OpenFDA further categorizes it under obstetrics/gynecology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sanctuary Health Sdn Bhd
FDA Applicant
Sanctuary Health Sdn. Bhd.

Sources (2)

  • FDA 510(k) K212037 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026