FDA.reportPublic FDA data

Surgical gown, single-use

Definition
A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
GUDID devices
2,582
Last updated
2026-10-24 13:18:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
16931918196756AllesetGRI Medical & Electronic Technology Co., Ltd.V91-6120-S12026-10-15
16942748412121AllesetGRI Medical & Electronic Technology Co., Ltd.V91-6122-S12026-10-15
16942748480953AllesetGRI Medical & Electronic Technology Co., Ltd.V91-6132-S12026-10-15
D832CT10L1PlasdentPLASDENT CORPORATIONCT10-L2026-10-12
D832CT10M1PlasdentPLASDENT CORPORATIONCT10-M2026-10-12
D832CT10S1PlasdentPLASDENT CORPORATIONCT10-S2026-10-12
D832CT10XL1PlasdentPLASDENT CORPORATIONCT10-XL2026-10-12
D832CT2L1PlasdentPLASDENT CORPORATIONCT2-L2026-10-12
D832CT2M1PlasdentPLASDENT CORPORATIONCT2-M2026-10-12
D832CT2S1PlasdentPLASDENT CORPORATIONCT2-S2026-10-12
D832CT2XL1PlasdentPLASDENT CORPORATIONCT2-XL2026-10-12
D832CT2XXL1PlasdentPLASDENT CORPORATIONCT2-XXL2026-10-12
D832CT6L1PlasdentPLASDENT CORPORATIONCT6-L2026-10-12
D832CT6M1PlasdentPLASDENT CORPORATIONCT6-M2026-10-12
D832CT6S1PlasdentPLASDENT CORPORATIONCT6-S2026-10-12
D832CT6XL1PlasdentPLASDENT CORPORATIONCT6-XL2026-10-12
D832JK10L1PlasdentPLASDENT CORPORATIONJK10-L2026-10-12
D832JK10M1PlasdentPLASDENT CORPORATIONJK10-M2026-10-12
D832JK10S1PlasdentPLASDENT CORPORATIONJK10-S2026-10-12
D832JK10XL1PlasdentPLASDENT CORPORATIONJK10-XL2026-10-12
D832JK2L1PlasdentPLASDENT CORPORATIONJK2-L2026-10-12
D832JK2M1PlasdentPLASDENT CORPORATIONJK2-M2026-10-12
D832JK2S1PlasdentPLASDENT CORPORATIONJK2-S2026-10-12
D832JK2XL1PlasdentPLASDENT CORPORATIONJK2-XL2026-10-12
D832JK2XXL1PlasdentPLASDENT CORPORATIONJK2-XXL2026-10-12
D832JK6L1PlasdentPLASDENT CORPORATIONJK6-L2026-10-12
D832JK6M1PlasdentPLASDENT CORPORATIONJK6-M2026-10-12
D832JK6S1PlasdentPLASDENT CORPORATIONJK6-S2026-10-12
D832JK6XL1PlasdentPLASDENT CORPORATIONJK6-XL2026-10-12
00850064198751Aligned Medical SolutionsAligned Medical Solutions19254S2026-09-23
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.S90-35302026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.S90-3020-S22026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.S90-30202026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.90-8030-S12026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.S90-35202026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.S90-3030-S22026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.S90-3530-S22026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.V91-6130-S22026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.S90-3520-S22026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.S90-30302026-09-29
10080196304752MEDLINEMEDLINE INDUSTRIES, INC.DYNJP2203S2016-10-14
10080196714100MEDLINEMEDLINE INDUSTRIES, INC.DYNJP20032016-10-14
20888277699561MEDLINEMEDLINE INDUSTRIES, INC.NONLV3402020-12-04
00612899045484EncompassEncompass Group, L.L.C.V4550-252023-06-22
00612899101104EncompassEncompass Group, L.L.C.V4550-25XB2023-06-22
07613327625172Steri-ShieldSTRYKER CORPORATION04248010002025-02-21
07613327625257Steri-ShieldSTRYKER CORPORATION04247212002025-02-21
07613327625288Steri-ShieldSTRYKER CORPORATION04247412002025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATION04248211002025-02-21
07613327625332Steri-ShieldSTRYKER CORPORATION04248212002025-02-21
07613327625349Steri-ShieldSTRYKER CORPORATION04248312002025-02-21
07613327625363Steri-ShieldSTRYKER CORPORATION04248512002025-02-21
07613327625370Steri-ShieldSTRYKER CORPORATION04249210002025-02-21
07613327625387Steri-ShieldSTRYKER CORPORATION04249410002025-02-21
07613327625394Steri-ShieldSTRYKER CORPORATION04249510002025-02-21
07613327625400Steri-ShieldSTRYKER CORPORATION04249310002025-02-21
07613327625417Steri-ShieldSTRYKER CORPORATION04249412002025-02-21
07613327625424Steri-ShieldSTRYKER CORPORATION04249311002025-02-21
07613327625431Steri-ShieldSTRYKER CORPORATION04249211002025-02-21
07613327625448Steri-ShieldSTRYKER CORPORATION04249312002025-02-21
07613327625455Steri-ShieldSTRYKER CORPORATION04249512002025-02-21
07613327625462Steri-ShieldSTRYKER CORPORATION04249212002025-02-21
07613327625479Steri-ShieldSTRYKER CORPORATION04249511002025-02-21
07613327625486Steri-ShieldSTRYKER CORPORATION04249411002025-02-21
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.SGS3B102-12026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.SGS3B103-12026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.SGS3B104-12026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.SGS3B201-12026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbH82520V2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbH82521V2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbH82522V2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbH82523V2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.DYNJP2228SG2026-07-17
00842942017230PRIMEDpriMED Medical Products IncPM4-68374XL2025-07-15
50885380134560CARDINAL HEALTHCardinal Health 200, LLC324740NA2026-06-24
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.SGS3B101-12026-06-25
10192253018974CONVERTORSCardinal Health 200, LLC90102019-09-04
10192253005943CONVERTORSCardinal Health 200, LLC90702019-04-08
00842942017223PRIMEDpriMED Medical Products IncPM4-683742025-07-15
00842942017254PRIMEDpriMED Medical Products IncPM4-68394XL2025-07-15