Primeline Medical Products, Inc.
Country not established
- Devices
- 9
What Primeline Medical Products, Inc. makes
Primeline Medical Products manufactures disposable surgical and procedural barriers, including pleated and ear-loop procedure masks, surgical gowns, cotton gauze sponges, shoe and head covers, and nonsterile femoral angiography drapes. Their product line also covers surgical equipment drapes and additional procedure masks designed for medical and surgical environments.
The company’s devices are regulated under FDA Class I, Class II, and Unclassified (U) categories, with most products listed via the 510(k) pathway. These items are intended for single-use in clinical settings and are based in the United States.
Catalogue
Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306 Ref K001951
Regimes: 510(k) Registry: 510(k)Primagard Surgical Gowns Ref K023266
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Primed Prime-Plus Cotton Gauze Sponges Ref K971075
Regimes: 510(k) Registry: 510(k)Primagard Surgical Gowns Ref K023117
Regimes: 510(k) Registry: 510(k)Primed Shoe Covers, Primed Head Covers Ref K971076
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Procedure Masks: PM4-301 And PM4-304 Ref K011789
Regimes: 510(k) Registry: 510(k)Primagard Surgical Equipment Drapes Ref K022868
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Primeline Medical Products, Inc. have in the registry?
The registry currently lists 9 devices for Primeline Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Primeline Medical Products, Inc.'s devices?
Among its 9 most recently registered devices, Primeline Medical Products, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Primeline Medical Products, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Primeline Medical Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Primeline Medical Products, Inc. in the registry?
The most recently registered devices listed for Primeline Medical Products, Inc. include PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306, PRIMAGARD SURGICAL GOWNS, PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP, PM4-308; PRM and PRIMED PRIME-PLUS COTTON GAUZE SPONGES.