FRUIT HEALTH

GUDID 10194422075528

100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK, NOT PROTECTED, SINGLE USE

Fruit of the Loom

Isolation gown, single-use
Primary Device ID10194422075528
NIH Device Record Key1cb5e63f-b390-4ca4-b342-244075a871a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRUIT HEALTH
Version Model NumberPI.408EGHT.O6J.XL.0.0
Company DUNS110555005
Company NameFruit of the Loom
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM
Phone1-800-551-7625
EmailFDA@FOTLINC.COM

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100194422075521 [Primary]
GS110194422075528 [Package]
Contains: 00194422075521
Package: POLY BAG [10 Units]
In Commercial Distribution
GS120194422075525 [Package]
Package: CARTON [10 Units]
In Commercial Distribution

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-21
Device Publish Date2022-03-11

On-Brand Devices [FRUIT HEALTH]

10194422075542100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
10194422075535100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
10194422075528100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
10194422108271100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC
10194422108264100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGI
10194422108257100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGIC

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.