Hilo Fit - Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352-19. Available in colors blue or yellow.
2025-01-23
Hilo Industries LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3034226814 | 3034226814 | Hilo Industries LLC | 1 | Y | 2026-01-01 | 7035 E Pecos Rd, Ste 1001 Bldg 1 Mesa AZ US 85212 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 334996 | 1342241615 | K093835 | BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN | FYA | 2011-02-04 |
| 334996 | 1332312366 | ||||
| 334996 | 1546696386 | ||||
| 334996 | 1619893125 | ||||
| 334996 | 2069923812 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FYA | 1 | 2011-02-04 |
GUDID#
Hilo Fit - 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.
2025-01-23
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 1, Model 11003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 2, Model 21004XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 3, Model 31003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 2, Model 21003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 3, Model 31004XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large
2022-09-07
Hilo Fit - Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 1, Model 11003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 2, Model 21004XL, Size XLarge
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 3, Model 31003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 2, Model 21003L, Size Large
2022-09-07
Hilo Fit - Isolation Gown, AAMI Level 3, Model 31004XL, Size XLarge
2022-09-07
Hilo Fit - Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow.
2022-07-08
Hilo Fit - 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.
2022-07-08
Hilo Fit - Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available in colors blue or yellow.
2022-07-08
Hilo Fit - 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.
2022-07-08
Hilo Pure - Digital Forehead Thermometer
2020-06-04