Quality Synthetics Intl, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Quality Synthetics Intl, Inc. makes
Quality Synthetics Intl, Inc. manufactures latex condoms in various formulations, including standard, ribbed, pink-colored, and versions with spermicidal lubricant. These products are designed for contraceptive use and barrier protection during sexual intercourse.
The company’s portfolio is regulated under FDA’s Class II device classification, with each product authorised via the 510(k) pathway. These condoms are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Safecon Condoms - Pink Color Ref K896623
Regimes: 510(k) Registry: 510(k)Safecon Condoms Ref K874399
Regimes: 510(k) Registry: 510(k)Safecon Condoms W/Spermicidal Lubricant Ref K883524
Regimes: 510(k) Registry: 510(k)Safecon Condoms - Ribbed Ref K884454
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quality Synthetics Intl, Inc. have in the registry?
The registry currently lists 4 devices for Quality Synthetics Intl, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quality Synthetics Intl, Inc.'s devices?
Among its 4 most recently registered devices, Quality Synthetics Intl, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Quality Synthetics Intl, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Quality Synthetics Intl, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quality Synthetics Intl, Inc. in the registry?
The most recently registered devices listed for Quality Synthetics Intl, Inc. include SAFECON CONDOMS - PINK COLOR, SAFECON CONDOMS, SAFECON CONDOMS W/SPERMICIDAL LUBRICANT and SAFECON CONDOMS - RIBBED.