Pro-Safe Professional Linens, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Pro-Safe Professional Linens, Inc. makes
Pro-Safe Professional Linens, Inc. manufactures reusable and disposable protective barriers for medical and dental procedures, including pocketed wraps, surgical instrument pouches, patient drapes, surgical gowns, and dental equipment protection devices. Their products are designed to maintain sterile environments during surgeries, examinations, and dental treatments, with variations like fast-wrap and specialized drapes for specific applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. These items are intended for use in healthcare settings in the United States, adhering to applicable medical device standards and registration requirements.
Catalogue
Pocketed Wraps #3009 A, B, C Ref K891210
Regimes: 510(k) Registry: 510(k)Aprons, Scrubs Slacks & Tops, Patient Drape Ref K891212
Regimes: 510(k) Registry: 510(k)Surgical Instrument Pouch #M102 Ref K891213
Regimes: 510(k) Registry: 510(k)Dental Surgical Wrap #3007 A, B, C Ref K891214
Regimes: 510(k) Registry: 510(k)Dental Equipment Protection Devices Ref K891216
Regimes: 510(k) Registry: 510(k)Fast Wrap #m 101 Ref K891215
Regimes: 510(k) Registry: 510(k)Surgical Gown #2001 Ref K891211
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pro-Safe Professional Linens, Inc. have in the registry?
The registry currently lists 7 devices for Pro-Safe Professional Linens, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pro-Safe Professional Linens, Inc.'s devices?
Among its 7 most recently registered devices, Pro-Safe Professional Linens, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Pro-Safe Professional Linens, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Pro-Safe Professional Linens, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pro-Safe Professional Linens, Inc. in the registry?
The most recently registered devices listed for Pro-Safe Professional Linens, Inc. include POCKETED WRAPS #3009 A, B, C, APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE, SURGICAL INSTRUMENT POUCH #M102 and DENTAL SURGICAL WRAP #3007 A, B, C.