Harmony Latex Dam, Harmony Non-Latex Dam
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203727 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)
This device is a barrier, standard, oral sex, as defined by its device type and nomenclature. It is designed to help reduce the risk of transmitting sexually transmitted infections during oral sex by providing a physical barrier against harmful pathogens.
The Harmony Latex Dam is a 6×10 inch latex sheet that is lightly scented and natural in color. The Harmony Non-Latex Dam is made of polyisoprene and is also individually packaged. Both versions are supplied as single-use oral barriers and are regulated as Class II medical devices under FDA 510(k) clearance K203727.
Frequently asked questions
What is the Harmony Latex Dam used for?
The Harmony Latex Dam is a barrier device designed to help reduce the risk of transmitting sexually transmitted infections during oral sex by providing a physical barrier against harmful pathogens.
How is the Harmony Non-Latex Dam supplied and is it reusable?
The Harmony Non-Latex Dam is supplied as an individually packaged, single-use oral barrier made of polyisoprene and is not intended for reuse.
What are the size and material differences between the Harmony Latex and Non-Latex Dams?
The Harmony Latex Dam is a 6×10 inch lightly scented natural-color latex sheet, while the Harmony Non-Latex Dam is the same size but made of polyisoprene material and also individually packaged.
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. Sources consulted: Harmony® — Pamco Distributing Inc., Harmony® Latex Dams — Pamco Distributing Inc., Harmony® Dams - Global Protection Corp., Harmony Non Latex Polyisoprene Oral Dams - totalaccessgroup.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203727 | Class II | Active |
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Manufacturer
- Manufacturer
- Pamco Distributing Inc
- FDA Applicant
- Pamco Distributing, Inc.
Sources (1)
- FDA 510(k) K203727 24 fields · synced Oct 1, 2026