FDA.reportPublic FDA data

Isolation gown, single-use

Definition
A 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.
GUDID devices
3,310
Last updated
2026-07-15 00:48:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00842942007934PRIMEDpriMED Medical Products IncPM4-57182XL2025-07-15
00842942008047PRIMEDpriMED Medical Products IncPM4-571822025-07-15
00842942008290PRIMEDpriMED Medical Products IncPM4-571632025-07-15
00842942008306PRIMEDpriMED Medical Products IncPM4-57163XL2025-07-15
00842942008450PRIMEDpriMED Medical Products IncPM4-584932025-07-15
00842942008467PRIMEDpriMED Medical Products IncPM4-58493XL2025-07-15
00842942009570PRIMEDpriMED Medical Products IncPM4-571622025-07-15
00842942009587PRIMEDpriMED Medical Products IncPM4-57162XL2025-07-15
00842942011047PRIMEDpriMED Medical Products IncPM4-571932025-07-15
00842942011788PRIMEDpriMED Medical Products IncPM4-581932025-07-15
00842942014406PRIMEDpriMED Medical Products IncPM4-206622025-07-15
00842942014420PRIMEDpriMED Medical Products IncPM4-256622025-07-15
00842942015175PRIMEDpriMED Medical Products IncPM4-57193XL2025-07-21
00842942015298PRIMEDpriMED Medical Products IncPM4-25662XL2025-07-15
00842942015304PRIMEDpriMED Medical Products IncPM4-574932025-07-21
00842942015427PRIMEDpriMED Medical Products IncPM4-20662XL2025-07-15
00842942015700PRIMEDpriMED Medical Products IncPM4-571922025-07-17
00842942015717PRIMEDpriMED Medical Products IncPM4-57192XL2025-07-17
00842942017261PRIMEDpriMED Medical Products IncPM4-571912025-07-17
00842942017278PRIMEDpriMED Medical Products IncPM4-57191XL2025-07-17
00842942017506PRIMED / CaracalpriMED Medical Products IncCPS20662U2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncCPS20662XL2025-11-26
10810141930510VIVIT SupplyVivit Supply LLC840Y2023-09-15
10810141930527VIVIT SupplyVivit Supply LLC841Y2023-09-15
10810141930534VIVIT SupplyVivit Supply LLC850Y2023-09-15
10810141930541VIVIT SupplyVivit Supply LLC851Y2023-09-15
10810141930596VIVIT SupplyVivit Supply LLC880Y2023-09-15
10810141930251VIVIT SupplyVivit Supply LLC810Y2023-09-15
10810141930268VIVIT SupplyVivit Supply LLC811Y2023-09-15
10810141930961VIVIT SupplyVivit Supply LLC240Y2023-10-24
10810141930978VIVIT SupplyVivit Supply LLC241Y2023-10-24
20192253061779CARDINAL HEALTHCardinal Health 200, LLCAT4498-XL2023-02-07
20885380151504CARDINAL HEALTHCardinal Health 200, LLCAT4437-BD2019-05-29
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCAT4437-XL2025-03-22
20885380151528CARDINAL HEALTHCardinal Health 200, LLCAT4450-BD2019-05-29
20885380151535CARDINAL HEALTHCardinal Health 200, LLCAT4450-XL2019-05-29
20885380151641CARDINAL HEALTHCardinal Health 200, LLCAT4488-2XL2019-08-02
20885380151719CARDINAL HEALTHCardinal Health 200, LLCAT4488-XL2019-08-02
20885380151733CARDINAL HEALTHCardinal Health 200, LLCAT4498-BD2019-08-02
20885380152303CARDINAL HEALTHCardinal Health 200, LLCAT4488-BD2017-10-20
00182921000403ALLCAREALLCARE, INCPA31261 2022-12-03
00191506004019EndoArmor™ PlusBOSTON SCIENTIFIC CORPORATIONSGE-499-102020-04-10
00194422075521FRUIT HEALTHFruit of the LoomPI.408EGHT.O6J.XL.0.02022-03-11
00194422075538FRUIT HEALTHFruit of the LoomPI.408EGHT.O6J.2X.0.02022-03-11
00194422075545FRUIT HEALTHFruit of the LoomPI.408EGHT.O6J.L.0.02022-03-11
00194422108250FRUIT HEALTHFruit of the LoomPI.421EGHT.O6J.2X.0.02022-04-19
00194422108267FRUIT HEALTHFruit of the LoomPI.421EGHT.O6J.XL.0.02022-04-19
00194422108274FRUIT HEALTHFruit of the LoomPI.421EGHT.O6J.L.0.02022-04-19
00195376201844StringKingString King Lacrosse LLCDIG.SMS.L2.L.BLU2022-07-18
00195376201851StringKingString King Lacrosse LLCDIG.SMS.L2.XL.BLU2022-07-18
00199536901001BluelineTransparent Supply Solutions Ltd.23202026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.23212026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.23102026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.23112026-05-15
00199536901322BluelineTransparent Supply Solutions Ltd.23322026-05-15
00199536901339BluelineTransparent Supply Solutions Ltd.23332026-05-15
00199536901346BluelineTransparent Supply Solutions Ltd.23462026-05-15
00199536901353BluelineTransparent Supply Solutions Ltd.23472026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.23502026-05-15
00199536901414BluelineTransparent Supply Solutions Ltd.23512026-05-15
00199536901421BluelineTransparent Supply Solutions Ltd.23942026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.23952026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.23972026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.23982026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.23992026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.23962026-05-15
00199536902008BluelineTransparent Supply Solutions Ltd.2802T2026-05-15
00199536902015BluelineTransparent Supply Solutions Ltd.2803T2026-05-15
00199536902022BluelineTransparent Supply Solutions Ltd.2804T2026-05-15
00199536902039BluelineTransparent Supply Solutions Ltd.2805T2026-05-15
00199536902046BluelineTransparent Supply Solutions Ltd.2806T2026-05-15
00199536902053BluelineTransparent Supply Solutions Ltd.2807T2026-05-15
00199536902107BluelineTransparent Supply Solutions Ltd.2842P2026-05-15
00199536902114BluelineTransparent Supply Solutions Ltd.2843P2026-05-15
00199536902121BluelineTransparent Supply Solutions Ltd.2844P2026-05-15
00199536902138BluelineTransparent Supply Solutions Ltd.2845P2026-05-15
00199536902145BluelineTransparent Supply Solutions Ltd.2846P2026-05-15
00199536902152BluelineTransparent Supply Solutions Ltd.2847P2026-05-15
00199536902206BluelineTransparent Supply Solutions Ltd.2812T2026-05-15
00199536902213BluelineTransparent Supply Solutions Ltd.2813T2026-05-15