FDA.reportPublic FDA data

Surgical/examination garment kit

Definition
A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.
GUDID devices
1,183
Last updated
2026-10-13 01:14:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00688162000054ProtexerICP MEDICAL, LLCICP-CPPSB 21"2022-10-31
00688162124002ProtexerICP MEDICAL, LLCICP-CPXP 242022-10-31
00688162400007ProtexerICP MEDICAL, LLCICP-CPPSB 24"2022-10-31
00688162800005ProtexerICP MEDICAL, LLCICP-CPPSB 28"2022-10-31
00813360021727ProtexerICP MEDICAL, LLCRR-5002021-06-01
00813360023042Full Coverage Isolation Gown #RR-300FCICP MEDICAL, LLC12017-01-04
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, BlueDynarex Corporation20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, BlueDynarex Corporation20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, BlueDynarex Corporation20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, BlueDynarex Corporation20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, BlueDynarex Corporation20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, WhiteDynarex Corporation20622021-09-01
00616784206325Lab Coats Knitted Cuffs & Collar with Pockets, Medium, WhiteDynarex Corporation20632021-09-01
00616784206424Lab Coats Knitted Cuffs & Collar with Pockets, Large, WhiteDynarex Corporation20642021-09-01
00616784206523Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, WhiteDynarex Corporation20652021-09-01
00616784206622Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, WhiteDynarex Corporation20662021-09-01
00616784207223Lab Coats Knitted Cuffs & Collar with Pockets, Small, BlueDynarex Corporation20722021-09-01
00616784207322Lab Coats Knitted Cuffs & Collar with Pockets, Medium, BlueDynarex Corporation20732021-09-01
00616784207421Lab Coats Knitted Cuffs & Collar with Pockets, Large, BlueDynarex Corporation20742021-09-01
00616784207520Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, BlueDynarex Corporation20752021-09-01
00616784207629Lab CoatDynarex Corporation20762021-09-01
00616784209227Lab Coats Knitted Cuffs & Collar with Pockets, Small, TealDynarex Corporation20922021-09-01
00616784209326Lab Coats Knitted Cuffs & Collar with Pockets, Medium, TealDynarex Corporation20932021-09-01
00616784209425Lab Coats Knitted Cuffs & Collar with Pockets, Large, TealDynarex Corporation20942021-09-01
00616784209524Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, TealDynarex Corporation20952021-09-01
00850084857218MedClickMedClick LLCMC-VGPF-10112026-07-22
00850084857225MedClickMedClick LLCMC-VGPF-10122026-07-22
00850084857232MedClickMedClick LLCMC-VGPF-10132026-07-22
00850084857249MedClickMedClick LLCMC-VGPF-10142026-07-22
00850084857256MedClickMedClick LLCMC-VGPF-20112026-07-22
00850084857263MedClickMedClick LLCMC-VGPF-20122026-07-22
00850084857270MedClickMedClick LLCMC-VGPF-20132026-07-22
00850084857287MedClickMedClick LLCMC-VGPF-20142026-07-22
00850084857294MedClickMedClick LLCMC-VGPF-30112026-07-22
00850084857300MedClickMedClick LLCMC-VGPF-30122026-07-22
00850084857317MedClickMedClick LLCMC-VGPF-30132026-07-22
00850084857324MedClickMedClick LLCMC-VGPF-30142026-07-22
00850084857331MedClickMedClick LLCMC-NGPF-40112026-07-22
00850084857348MedClickMedClick LLCMC-NGPF-40122026-07-22
00850084857355MedClickMedClick LLCMC-NGPF-40132026-07-22
00850084857362MedClickMedClick LLCMC-NGPF-40142026-07-22
00850084857379MedClickMedClick LLCMC-NGPF-50112026-07-22
00850084857386MedClickMedClick LLCMC-NGPF-50122026-07-22
00850084857393MedClickMedClick LLCMC-NGPF-50132026-07-22
00850084857409MedClickMedClick LLCMC-NGPF-50142026-07-22
00810010894946Aero-MedAERO-MED, LLCAMM212752026-03-17
00810010894953Aero-MedAERO-MED, LLCAMM3675F2026-03-17
00840456218402JMUJMU DENTAL, INC254060222026-07-06
00840456218419JMUJMU DENTAL, INC254060232026-07-06
00840456218426JMUJMU DENTAL, INC254060242026-07-06
00840456218433JMUJMU DENTAL, INC254060252026-07-06
00840456218440JMUJMU DENTAL, INC254060262026-07-06
00840456218457JMUJMU DENTAL, INC254060272026-07-06
00840456218464JMUJMU DENTAL, INC254060282026-07-06
00840456218471JMUJMU DENTAL, INC254060292026-07-06
00840456218488JMUJMU DENTAL, INC254060302026-07-06
00840456218495JMUJMU DENTAL, INC254060312026-07-06
00840456220894JMUJMU DENTAL, INC254050322026-07-06
00840456220900JMUJMU DENTAL, INC254050332026-07-06
00840456220917JMUJMU DENTAL, INC254050342026-07-06
00840456220924JMUJMU DENTAL, INC254050312026-07-06
00840456220931JMUJMU DENTAL, INC254050282026-07-06
00840456220948JMUJMU DENTAL, INC254050292026-07-06
00840456220955JMUJMU DENTAL, INC254060322026-07-06
00840456220962JMUJMU DENTAL, INC254060332026-07-06
00840456220979JMUJMU DENTAL, INC254060352026-07-06
00840456220986JMUJMU DENTAL, INC254060342026-07-06
00840456224328JMUJMU DENTAL, INC254050302026-07-06
00347682682354Medi-First Blue Medium Latex Finger CotMedique Products682352019-07-12
00347682700355Medi-First Blue Large Latex Finger CotMedique Products700352019-07-12
00347682704353Medi-First Latex Medium Finger CotsMedique Products704352019-07-12
00347682722357Medi-First Large Latex Finger CotMedique Products722352019-07-12
00347682736996Medi-First Disposable Nitrile GlovesMedique Products736992019-07-19
00347682791513Medi-First Plus Sani Safe Glove DispenserMedique Products7915MFP2019-07-12
00347682791551Green Guard Sani Safe Glove DispenserGreenguard79152019-06-26
00612479119987McKessonMCKESSON MEDICAL-SURGICAL INC.380311002020-07-14
00612479119994McKessonMCKESSON MEDICAL-SURGICAL INC.380411002020-07-14
00612479120006McKessonMCKESSON MEDICAL-SURGICAL INC.380511002020-07-14
00612479120013McKessonMCKESSON MEDICAL-SURGICAL INC.446011002020-07-14
00612479120020McKessonMCKESSON MEDICAL-SURGICAL INC.444511002020-07-14