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
2,542
Last updated
2026-09-14 22:39:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.90-8030ST2026-06-04
00191506005917EndoArmor™ +BOSTON SCIENTIFIC CORPORATIONM005019712022-05-13
00192253010537CONVERTORSCardinal Health 200, LLC90712019-04-02
00192253010575CONVERTORSCardinal Health 200, LLC95602019-04-02
00326053117558Regard™Resource Optimization & Innovation, L.L.C.A3SRGSTSM-REG2020-09-10
00326053117565Regard™Resource Optimization & Innovation, L.L.C.A3SRGSTL-REG2020-09-10
00326053117572Regard™Resource Optimization & Innovation, L.L.C.A3SRGSTXL-REG2020-09-10
00326053117589Regard™Resource Optimization & Innovation, L.L.C.A3SRGST2X-REG2020-09-10
00326053117602SurgiPlusResource Optimization & Innovation, L.L.C.66-3130-S2020-09-15
00326053117756RegardResource Optimization & Innovation, L.L.C.A3ISRGSTXL-REG2020-05-26
00326053117763RegardResource Optimization & Innovation, L.L.C.A3ISRGSTXXL-REG2020-05-26
00326053117992Regard™Resource Optimization & Innovation, L.L.C.A3SRGST4X-REG2021-04-20
00612899134034TECHStyles Gown BackTechstyles13-403N2016-08-31
00612899134041TECHStyles Gown Back, XLTechstyles13-404N2016-08-31
00612899134058TECHStyles Gown BackTechstyles13-405N2016-08-31
00630140012276CONVERTORSCardinal Health 200, LLC395152016-06-28
00630140012290CONVERTORSCardinal Health 200, LLC395452016-06-28
00630140020394CONVERTORSCardinal Health 200, LLC95112016-06-28
00630140020400CONVERTORSCardinal Health 200, LLC95152016-06-22
00630140020417CONVERTORSCardinal Health 200, LLC95412016-07-13
00630140020424CONVERTORSCardinal Health 200, LLC95452016-06-28
00630140025412CONVERTORSCardinal Health 200, LLC95752016-06-28
00630140025429CONVERTORSCardinal Health 200, LLC95712016-06-28
00630140029281CONVERTORSCardinal Health 200, LLC90112016-07-14
00630140030379CONVERTORSCardinal Health 200, LLC395752016-06-28
00630140030621CONVERTORSCardinal Health 200, LLC90712016-07-14
00630140040606CONVERTORSCardinal Health 200, LLC95602016-07-14
00630140933953CONVERTORSCardinal Health 200, LLC90102016-06-28
00748426089796MICROTEKMicrotek Medical LLC12016-11-04
00748426090112MICROTEKMicrotek Medical LLC12016-12-20
00748426090891MICROTEKMicrotek Medical LLC12016-12-26
00748426090907MICROTEKMicrotek Medical LLC12016-12-26
00748426091607MICROTEKMicrotek Medical LLC12016-12-26
00749756173575DeRoyalDEROYAL INDUSTRIES, INC.32-9472016-09-12
00749756566100DeRoyalDEROYAL INDUSTRIES, INC.99-18413-D2016-09-12
00749756566124DeRoyalDEROYAL INDUSTRIES, INC.99-18414-D2016-09-12
00749756566131DeRoyalDEROYAL INDUSTRIES, INC.99-5281-D2016-09-12
00749756566155DeRoyalDEROYAL INDUSTRIES, INC.99-5178-D2016-09-12
00749756566223DeRoyalDEROYAL INDUSTRIES, INC.99-17923-D2016-09-12
00749756566230DeRoyalDEROYAL INDUSTRIES, INC.99-5285-D2016-09-12