FDA.reportPublic FDA data

FRUIT HEALTH

Primary DI
00194422108250
Brand
FRUIT HEALTH
Company
Fruit of the Loom
Model
PI.421EGHT.O6J.2X.0.0
Device description
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE
Published
2022-04-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10194422108257PackageGS110Not in Commercial Distribution
20194422108254PackageGS110Not in Commercial Distribution
00194422108250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019442210825710194422108257
2019442210825420194422108254
00194422108250001944221082501944221082500194422108250

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-551-7625FDA@FOTLINC.COM

Regulatory Flags#

DUNS number
110555005
Device count
1
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
00194422075521FRUIT HEALTHPI.408EGHT.O6J.XL.0.02022-03-11
00194422075538FRUIT HEALTHPI.408EGHT.O6J.2X.0.02022-03-11
00194422075545FRUIT HEALTHPI.408EGHT.O6J.L.0.02022-03-11
00194422108267FRUIT HEALTHPI.421EGHT.O6J.XL.0.02022-04-19
00194422108274FRUIT HEALTHPI.421EGHT.O6J.L.0.02022-04-19
10194422108257FRUIT HEALTHPI.421EGHT.O6J.2X.0.02022-04-19
10194422108264FRUIT HEALTHPI.421EGHT.O6J.XL.0.02022-04-19
10194422108271FRUIT HEALTHPI.421EGHT.O6J.L.0.02022-04-19
10194422075528FRUIT HEALTHPI.408EGHT.O6J.XL.0.02022-03-11
10194422075535FRUIT HEALTHPI.408EGHT.O6J.2X.0.02022-03-11
10194422075542FRUIT HEALTHPI.408EGHT.O6J.L.0.02022-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10198956101395CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956101425CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956102163CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-10
10198956099128CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101746CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-06
10198956101401CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956101906CARDINAL HEALTHCardinal Health 200, LLCOEA2025-06-05
10198956089303CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-22
10197106988251CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-19
10198956089143CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-14
10197106988176CARDINAL HEALTHCardinal Health 200, LLCOEA2025-05-13
10197106824832CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106860120CARDINAL HEALTHCardinal Health 200, LLCOEA2025-01-02
10197106873113CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-18
10197106861936CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106868249CARDINAL HEALTHCardinal Health 200, LLCOEA2024-12-11
10197106779781CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13