FDA.reportPublic FDA data

Shoe cover

Definition
A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.
GUDID devices
250
Last updated
2026-03-17 18:51:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10810132044332HCSConcordance Healthcare Solutions LLC3011SHU2026-03-09
10810132044349HCSConcordance Healthcare Solutions LLC3011SHXL2026-03-09
10197344133123MEDLINEMEDLINE INDUSTRIES, INC.NON28858GV2026-03-06
10197344151578MEDLINEMEDLINE INDUSTRIES, INC.NON28858GV42026-03-06
00810180843126Shoe CoverDynarex Corporation21312021-06-21
00810180843133Shoe CoverDynarex Corporation21322021-06-21
00810180843140Shoe CoverDynarex Corporation21342021-06-21
10688162000020ProtexerICP MEDICAL, LLCICP-SCNS2025-08-19
10813360021786ProtexerICP MEDICAL, LLCICP-SCNS2025-08-19
10813360021793ProtexerICP MEDICAL, LLCICP-SCXT2025-08-19
00810184641407GCB Medical SupplyGCB MEDICAL LLCGCB12122025-07-24
00810184641414GCB Medical SupplyGCB MEDICAL LLCGCB1212XL2025-07-24
00810184641421GCB Medical SupplyGCB MEDICAL LLCGCB12132025-07-24
00810184641438GCB Medical SupplyGCB MEDICAL LLCGCB1213XL2025-07-24
00810184641445GCB Medical SupplyGCB MEDICAL LLCGCB22112025-07-24
00810184641452GCB Medical SupplyGCB MEDICAL LLCGCB2211XL2025-07-24
00810184642763GCB Medical SupplyGCB MEDICAL LLCGCB12112025-07-24
00810184642770GCB Medical SupplyGCB MEDICAL LLCGCB1211XL2025-07-24
00612479277038McKessonMCKESSON MEDICAL-SURGICAL INC.16-BCNSMFB9-OSFM2025-07-28
00612479277052McKessonMCKESSON MEDICAL-SURGICAL INC.16-BCNSMFB9-LX2025-07-28
00612479277076McKessonMCKESSON MEDICAL-SURGICAL INC.16-BCNSHFB9-OSFM2025-07-28
00612479277090McKessonMCKESSON MEDICAL-SURGICAL INC.16-BCNSHFB9-XL2025-07-28
00850061859136GCB Medical Supply NovaplusGCB MEDICAL LLCVGCB02112025-07-23
20197344103970MEDLINEMEDLINE INDUSTRIES, INC.NON274502025-04-05
00612479250543McKessonMCKESSON MEDICAL-SURGICAL INC.16-65102025-03-18
00612479250574McKessonMCKESSON MEDICAL-SURGICAL INC.16-65572025-03-18
00690521019201Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1216-PDB2025-02-14
00690521019218Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1226-PDB2025-02-14
00690521020948Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1210-PB2025-02-14
00690521020955Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1616-PDB2025-02-14
00690521020986Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1216-PB2025-02-14
00690521021365Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1226-PB2025-02-14
00690521021396Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1616-PB2025-02-14
00690521021419Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1922-PDB2025-02-14
00690521021426Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1922-PB2025-02-14
00690521022683Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-2112-NPB2025-02-14
00690521022690Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-2122-NPB2025-02-14
00690521022881Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1220-PB2025-02-14
00690521022904Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-2112-NPDB2025-02-14
00690521022928Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-2122-NPDB2025-02-14
00690521025172Batrik ShoozCovers™ Batrik Medical Manufacturing IncSC-1610-PB2025-02-14
10326053120777Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.CVRBTELSXL-REG2025-02-06
10326053120784Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.CVRBTTIEXL-REG2025-01-28
TQ26126151040Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.126151042024-12-09
20810141933211VIVIT SupplyVivit Supply LLC8450FW2024-11-29
20810141933228VIVIT SupplyVivit Supply LLC8451FW2024-11-29
10850037747464Extra Large Blue Shoe CoverSafesource Direct, L.L.C.SC30022024-10-10
10850037747471Universal Shoe Cover Super TreadSafesource Direct, L.L.C.SC30032024-10-10
10850037747488Extra Large Extra Traction Shoe CoverSafesource Direct, L.L.C.SC30042024-10-10
30810087350179CoulmedCoulmed Products Group LLCDI-59052023-01-06
30197344036114MedlineMEDLINE INDUSTRIES, INC.NON27LV302024-02-16
30197344074451MedlineMEDLINE INDUSTRIES, INC.NON27LV30XL2024-02-16
10197344036042MedlineMEDLINE INDUSTRIES, INC.CRI2002G2024-01-01
10197344036059MedlineMEDLINE INDUSTRIES, INC.CRI2003G2024-01-01
10197344029600MedlineMEDLINE INDUSTRIES, INC.NON31858NP2023-12-22
10197344029617MedlineMEDLINE INDUSTRIES, INC.NON31859NP2023-12-19
40080196745792MedlineMEDLINE INDUSTRIES, INC.CRI20002023-10-12
20810141930432VIVIT SupplyVivit Supply LLC8440FW2023-09-15
20810141930449VIVIT SupplyVivit Supply LLC8441FW2023-09-15
20810141930623Vivit SupplyVivit Supply LLC8430FW2023-09-15
20810141930630Vivit Suppy Vivit Supply LLC8431FW2023-09-15
20810141930920VIVIT SupplyVivit Supply LLC9340FW2023-09-15
20810141930937VIVIT SupplyVivit Supply LLC9341FW2023-09-15
14719882253161CopioumedCopious International Inc.SHN0W111-12023-08-25
14719882253185CopioumedCopious International Inc.SHN0B111-12023-08-25
00097604459549Tronex International, Inc.TRONEX INTERNATIONAL, INC.4595B2023-08-28
00097604469753Tronex International, Inc.TRONEX INTERNATIONAL, INC.4697B2023-08-28
06974669350209MDHCMDHC Life Technologies (Kunshan) Co., LTD.1 pair2023-07-06
10849233004822Busse Hospital DisposablesROBERT BUSSE & CO., INC.3382023-06-16
10849233004884Busse Hospital DisposablesROBERT BUSSE & CO., INC.3462023-06-16
10849233004891Busse Hospital DisposablesROBERT BUSSE & CO., INC.3472023-06-16
20849233004874Busse Hospital DisosablesROBERT BUSSE & CO., INC.3402023-06-16
20849233005000Busse Hospital DisposablesROBERT BUSSE & CO., INC.3482023-06-16
00850037747269SafeSource Shoe CoversSafesource Direct, L.L.C.SC30012023-05-16
10810132040969HCSConcordance Healthcare Solutions LLCHCS30122023-04-21
20810132040010HCSConcordance Healthcare Solutions LLCHCS30112023-04-21
00097604470025Tronex International, Inc.TRONEX INTERNATIONAL, INC.SMS4700B2023-04-10
00097604472241Tronex International, Inc.TRONEX INTERNATIONAL, INC.SMS4722B2023-04-10
00097604474757Tronex International, Inc.TRONEX INTERNATIONAL, INC.SMS4747B2023-04-10
06971642800706RTMEDShandong Haidike Medical Products Co., Ltd.Nonwoven fabric type, PVC type 50 / bag, 100 / bag2022-12-07