FDA.reportPublic FDA data

Robert Duffy

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96152703002750002Robert Duffy1N2026-01-0116405 Summer Sage Road Poway CA US 92064
30095405723009540572Robert Duffy1N2026-01-0116405 Summer Sage Road Poway CA US 92064
30172290093017229009Robert Duffy1N2026-01-0116405 Summer Sage Road Poway CA US 92064
30207558153020755815Robert Duffy1N2026-01-0116405 Summer Sage Road Poway CA US 92064
30131874863013187486Robert Duffy1N2020-04-2516405 Summer Sage Road Poway CA US 92064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
170761029867367K252964PRIMED Surgical and Procedure MasksFXX2025-11-04
170761664221616K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG2024-10-07
170761917921151K240286PRIMED Surgical Masks and PRIMED Procedure MasksFXX2024-08-26
170761227730492K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG2024-05-24
170761255145287K213427PRIMED Pediatric FacemaskOXZ2022-11-22
170761910909434K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17
2097602049058658K162923NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUELZA2017-02-06
170761046944930K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC2016-11-04
2097601046944930K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC2016-11-04
2097601925552166K142283Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)LZA2015-01-16
170761748673416K081633PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSFXX2008-08-11
2097601748673416K081633PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSFXX2008-08-11
170761046195442
2097601157429416
2097601267201577
2097601350601945
170761472945890
2097601803324753
2097602026860982
2880571029867367
2965511029867367
2965511046944930
1384821046944930
2965511157429416
170761157429416
1384821157429416
2880571255145287
1384821267201577
170761267201577
2965511350601945
1384821350601945
170761350601945
170761711262199
2965511748673416
2880571748673416
1384821803324753
170761803324753
1384821815627125
170761815627125
170761833923997
1384821833923997
2880571917921151
2965511917921151
1384822026860982
170762026860982
170762071753121
1384822071753121

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FXX42025-11-04
LZA32018-08-17
FRG22024-10-07
FYC22016-11-04
OXZ12022-11-22