Hilo Industries LLC

Address:10432 BALLS FORD RD,Manassas,VA,20109,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Non-Surgical Isolation Gown (OEA) (10)

Premarket Exempt

No Yes

Clear

Hilo Fit - 00810107330227 Catalog Number :

Device Description : Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets r Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow.

Device Class :

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330234 Catalog Number :

Device Description : Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow.

Device Class :

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330302 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330319 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330326 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330333 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330340 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330357 Catalog Number :

Device Description : Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330371 Catalog Number :

Device Description : Isolation Gown, AAMI Level 1, Model 11003L, Size Large

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

Hilo Fit - 00810107330395 Catalog Number :

Device Description : Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge

Device Class : 1

Duns Number: 117472180

Premarket Exempt : Yes

Product Code : OEA

Prescription Use : No

Device Count : 100

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