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
3,311
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
00199536902220BluelineTransparent Supply Solutions Ltd.2814T2026-05-15
00199536902237BluelineTransparent Supply Solutions Ltd.2815T2026-05-15
00199536902244BluelineTransparent Supply Solutions Ltd.2816T2026-05-15
00199536902251BluelineTransparent Supply Solutions Ltd.2817T2026-05-15
00199536902305BluelineTransparent Supply Solutions Ltd.2852P2026-05-15
00199536902312BluelineTransparent Supply Solutions Ltd.2853P2026-05-15
00199536902329BluelineTransparent Supply Solutions Ltd.2854P2026-05-15
00199536902336BluelineTransparent Supply Solutions Ltd.2855P2026-05-15
00199536902343BluelineTransparent Supply Solutions Ltd.2856P2026-05-15
00199536902350BluelineTransparent Supply Solutions Ltd.2857P2026-05-15
00326053117428RegardResource Optimization & Innovation, L.L.C.A2ISOGULNS-REG2020-05-15
00326053117435RegardResource Optimization & Innovation, L.L.C.A2ISOGXLNS-REG2020-05-15
00326053117442RegardResource Optimization & Innovation, L.L.C.A2ISOG2XLNS-REG2020-05-15
00326053117459Regard™Resource Optimization & Innovation, L.L.C.A4ISOGULNS-REG2020-09-10
00326053117466Regard™Resource Optimization & Innovation, L.L.C.A4ISOGXLNS-REG2020-09-10
00326053117770Regard™Resource Optimization & Innovation, L.L.C.A4ISOGXLNS3-REG2020-09-17
00326053117978Regard™Resource Optimization & Innovation, L.L.C.A4ISOGULNS-REG2024-11-27
00326053117985Regard™Resource Optimization & Innovation, L.L.C.A4ISOGXLNS-REG2024-11-27
00326053118005Regard™Resource Optimization & Innovation, L.L.C.A4ISOG2XLNS-REG2021-04-22
00326053118487Regard™Resource Optimization & Innovation, L.L.C.A2ISOG3XLNS-REG2022-05-03
00381342000454Health Supply US Level 2 GownHealth Supply US, LLCHSUS-L2-EC-L2024-06-18
00381342000461Health Supply US Level 2 GownHealth Supply US, LLCHSUS-L2-EC-XL2024-06-18
00381342000577Health Supply US Level 2 GownHealth Supply US, LLCHSUS-L2-EC-2XL2024-06-18
00381342000584Health Supply US Level 2 GownHealth Supply US, LLCHSUS-L2-EC-M2024-06-18
00381342000591Health Supply US Level 2 GownHealth Supply US, LLCHSUS-L2-EC-S2024-06-18
00612479203136McKessonMCKESSON MEDICAL-SURGICAL INC.16-OHBCPE2019-10-22
00612479203150McKessonMCKESSON MEDICAL-SURGICAL INC.16-OHYSPNBD2019-10-22
00612479203174McKessonMCKESSON MEDICAL-SURGICAL INC.16-OHYSMS2019-10-22
00612479203198McKessonMCKESSON MEDICAL-SURGICAL INC.16-OHBPOLY2019-10-22
00612479203211McKessonMCKESSON MEDICAL-SURGICAL INC.16-OHYFBAAMI22019-10-22
00612479234468McKessonMCKESSON MEDICAL-SURGICAL INC.16-58KVM2018-09-12
00612479234482McKessonMCKESSON MEDICAL-SURGICAL INC.16-58KVL2018-09-12
00612479234505McKessonMCKESSON MEDICAL-SURGICAL INC.16-58KVX2018-09-12
00612479234529McKessonMCKESSON MEDICAL-SURGICAL INC.16-58KV2X2018-09-12
00612479234543McKessonMCKESSON MEDICAL-SURGICAL INC.16-58KOL2018-09-12
00612479234567McKessonMCKESSON MEDICAL-SURGICAL INC.16-54KVM2018-09-12
00612479234581McKessonMCKESSON MEDICAL-SURGICAL INC.16-54KVL2018-09-12
00612479234604McKessonMCKESSON MEDICAL-SURGICAL INC.16-55KVX2018-09-12
00612479234628McKessonMCKESSON MEDICAL-SURGICAL INC.16-55KV2X2018-09-12
00612479234642McKessonMCKESSON MEDICAL-SURGICAL INC.16-54KTL2018-09-12