FDA.reportPublic FDA data

Surgical gown, single-use

Definition
A garment made of natural and/or synthetic materials intended to be worn 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
1,134
Last updated
2021-03-30 08:51:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850024023543Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E1044502021-03-22
00850024023567Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E1044602021-03-22
00850024023581Exact MedicalEXACT MEDICAL MANUFACTURING, INC.E1044702021-03-22
008500291912093A MEDICAL3A Medical Products Co.,Ltd210012021-03-18
008500291912163A MEDICAL3A Medical Products Co.,Ltd3AJS00012021-03-18
008500291912233A MEDICAL3A Medical Products Co.,Ltd310012021-03-18
008500291912303A MEDICAL3A Medical Products Co.,Ltd210012021-03-18
20888277629292MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DYNJP2902T2021-03-18
20888277629285MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DYNJP2901T2021-03-16
20888277629322MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DYNJP2907T2021-03-16
40080196311034MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.DYNJPE21042021-03-16
008500291910633A MEDICAL3A Medical Products Co.,LtdS40022021-03-10
008500291910703A MEDICAL3A Medical Products Co.,LtdS40032021-03-10
008500291910873A MEDICAL3A Medical Products Co.,LtdS40042021-03-10
008500291910943A MEDICAL3A Medical Products Co.,LtdS40052021-03-10
008500291911003A MEDICAL3A Medical Products Co.,LtdS30012021-03-10
008500291911173A MEDICAL3A Medical Products Co.,LtdS30022021-03-10
008500291911553A MEDICAL3A Medical Products Co.,LtdS40012021-03-10
008500291911623A MEDICAL3A Medical Products Co.,LtdS40022021-03-10
008500291911793A MEDICAL3A Medical Products Co.,LtdS40032021-03-10
008500291911863A MEDICAL3A Medical Products Co.,LtdS40042021-03-10
008500291911933A MEDICAL3A Medical Products Co.,LtdS40052021-03-10
008500291910013A MEDICAL3A Medical Products Co.,LtdS30012021-03-09
008500291910183A MEDICAL3A Medical Products Co.,LtdS30022021-03-09
008500291910563A MEDICAL3A Medical Products Co.,LtdS40012021-03-09
008500291911243A MEDICAL3A Medical Products Co.,LtdS30032021-03-09
008500291911313A MEDICAL3A Medical Products Co.,LtdS30042021-03-09
008500291911483A MEDICAL3A Medical Products Co.,LtdS30052021-03-09
10885380134661CARDINAL HEALTHCardinal Health 200, LLC90970NA2021-03-05
008500291910253A Medical3A Medical Products Co.,LtdS30032021-03-03
008500291910323A Medical3A Medical Products Co.,LtdS30042021-03-03
008500291910493A Medical3A Medical Products Co.,LtdS30052021-03-03
00850022960321Texas Medical TechnologyTexas Medical Technology IncGWS-03-M-B2021-02-16
00850022960338Texas Medical TechnologyTexas Medical Technology IncGWS-03-L-B2021-02-16
00850022960345Texas Medical TechnologyTexas Medical Technology IncGWS-03-XL-B2021-02-16
00850022960352Texas Medical TechnologyTexas Medical Technology IncGWS-03-XXL-B2021-02-16
00850022960369Texas Medical TechnologyTexas Medical Technology IncGWS-03-S-B2021-02-16
06931918112957AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4020-HB2021-02-23
06931918117334AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4230-W12021-02-23
06931918120143Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.Model 80086252021-02-23
06931918140325Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.Model 80086232021-02-23
06931918150348Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.Model 80347192021-02-23
06931918157828AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4330-HB2021-02-23
06931918164314Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.Model 80086242021-02-23
06931918168190AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-20402021-02-23
06931918172548AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4020-W12021-02-23
06931918176911AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4220-W12021-02-23
06931918179639Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.Model 80126532021-02-23
06931918183919AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4030-HB2021-02-23
06931918190382AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1230-HB2021-02-23
36931918176165AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-3831-S22021-02-09
26931918112494AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-2020-S22021-02-02
26931918133086AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1331-S12021-02-02
26931918134526AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-2030-S22021-02-02
26931918134984AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1320-S12021-02-02
26931918160792AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1240-S12021-02-02
26931918172474AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-2040-S22021-02-02
26931918176427AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1210-S12021-02-02
26931918184682AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-4030-S22021-02-02
26931918192847AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1330-S12021-02-02
26931918198467AllesetGRI Medical & Electronic Technology Co., Ltd.Model 90-1200-S12021-02-02
00854150007316ORIOPERATING ROOM INNOVATIONS, INC.HF-XL2021-01-28
00854150007330ORIOPERATING ROOM INNOVATIONS, INC.HF-XXL2021-01-28
20193489100362MedlineMEDLINE INDUSTRIES, INC.SPT-2227SMSCS2021-01-26
20888277725628MedlineMEDLINE INDUSTRIES, INC.DYNJP2373P2021-01-26
40884389029696MedlineMEDLINE INDUSTRIES, INC.SPT-2103SMSCS2021-01-26
40884389110516MedlineMEDLINE INDUSTRIES, INC.SPT-2201SMSCS2021-01-26
30680651771491HalyardO&M HALYARD, INC.771492020-12-31
30680651771538HalyardO&M HALYARD, INC.771532020-12-31
20817583021483Critical CoverALPHA PRO TECH INCFK-J2141-12020-12-21
20817583021490Critical CoverALPHA PRO TECH INCFK-J2141-22020-12-21
20817583021506Critical CoverALPHA PRO TECH INCFK-J2141-32020-12-21
20817583021513Critical CoverALPHA PRO TECH INCFK-J2141-42020-12-21
20817583021520Critical CoverALPHA PRO TECH INCFK-J2141-52020-12-21
20817583021537Critical CoverALPHA PRO TECH INCFK-J2141-62020-12-21
20817583021544Critical CoverALPHA PRO TECH INCFK-J2141-72020-12-21
20817583021551Critical CoverALPHA PRO TECH INCFK-J2491-22020-12-21
20817583021568Critical CoverALPHA PRO TECH INCFK-J2491-32020-12-21
20817583021575Critical CoverALPHA PRO TECH INCFK-J2491-42020-12-21
20817583021582Critical CoverALPHA PRO TECH INCFK-J2491-52020-12-21