FDA.reportPublic FDA data

Hilo Fit

Primary DI
00810107330340
Brand
Hilo Fit
Company
Hilo Industries LLC
Model
22703L
Device description
Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large
Published
2022-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810107330340PrimaryGS10
10810107330248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810107330340008101073303408101073303400810107330340
1081010733024810810107330248

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
117472180
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810107330207Hilo Fit22003L2025-01-23
20810107330214Hilo Fit22004XL2025-01-23
00810107330302Hilo Fit32704XL2022-09-07
00810107330319Hilo Fit32703L2022-09-07
00810107330326Hilo Fit12703L2022-09-07
00810107330333Hilo Fit12704XL2022-09-07
00810107330357Hilo Fit22704XL2022-09-07
00810107330371Hilo Fit11003L2022-09-07
00810107330395Hilo Fit11004XL2022-09-07
00810107330418Hilo Fit21004XL2022-09-07
00810107330449Hilo Fit31003L2022-09-07
00810107330456Hilo Fit21003L2022-09-07
00810107330470Hilo Fit31004XL2022-09-07
10810107330293Hilo Fit32704XL2022-09-07
10810107330286Hilo Fit32703L2022-09-07
10810107330262Hilo Fit12703L2022-09-07
10810107330279Hilo Fit12704XL2022-09-07
10810107330248Hilo Fit22703L2022-09-07
10810107330255Hilo Fit22704XL2022-09-07
10810107330361Hilo Fit11003L2022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
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10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
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10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13