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SRI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10558921000111202SRI Healthcare, LLC1N2026-01-011416 DOGWOOD WAY MEBANE NC US 27302
10559541000113384SRI Healthcare, LLC1N2026-01-015155 WESTPARK DR SW ATL GA US 30336
10655973002805559SRI Healthcare, LLC1N2026-01-016024 Century Oaks Dr CHATTANOOGA TN US 37416
15276071527607SRI Healthcare, LLC1N2026-01-017086 INDUSTRIAL ROW RD. MASON OH US 45040
10002665641000266564SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.1N2026-01-0110 Soi 10 Phetkasem Road Hat Yai, Hat Yai Songkhla TH 90110
30141482873014148287Sri Trang USA, Inc.1Y2026-01-01410 North Michigan Avenue, Suite N740 Chicago IL US 60611
30195850993019585099Srihari Acharya1N2026-01-01600 Shiloh Rd Plano TX US 75074
30381874583038187458Sri Ramya Vemulakonda1N2026-01-011618 W Augusta Blvd Apt 2 Chicago IL US 60622
30151697433015169743SRIT INDIA PRIVATE LIMITED1N2020-04-25Harish Kumar M SRIT House, #133/1B, ITPL Main Road Kundalahalli Karnataka IN 560037

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2135151847072854K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
2135171847072854K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
2135141847072854K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
2137301966566129K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYY1997-05-06
2137301755187295K954880LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)LYY1995-11-15
2135171821251785K915502MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPESFYA1992-04-29
2135151821251785K915502MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPESFYA1992-04-29
2135141821251785K915502MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPESFYA1992-04-29
3378362048192772K241091SIMEOX 200 Airway Clearance DeviceSDT2024-12-23
2137301423790600K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- BlueLZA2024-07-02
2137301596220148K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)LZA2024-05-13
2137301894526795K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and FentanylLZA2022-11-20
2137301686829045K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural WhiteLYY2022-08-09
2137301144313220K212309Non-sterile, Powder-Free Latex Examination GloveLYY2022-04-08
2137301199671459K203191LYDUS Nitrile Examination Gloves, Powder FreeLZA2021-02-12
2137301935426798K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and FentanylLZA2020-04-09
2137301444641110K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - OysterLZA2020-03-20
2137301662665291K182308Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy DrugsLZA2019-05-30
2137301537819158K182241Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy DrugsLZA2019-03-11
2135171458527426K152884DermaTherapy Bed LinensFMW2016-06-20
2137301717833055K142685NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREELZA2015-02-11
2137301767161457K122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZA2012-09-10
2137301127717430K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUELZA2012-12-27
2137301408412453K111133NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)LYY2011-06-24
2137301495575314K110921NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2011-04-15
2135171188400655K10286484E SERIES SINGLE PLY WRAPPERFRG2011-01-14
2135141188400655K10286484E SERIES SINGLE PLY WRAPPERFRG2011-01-14
2135151188400655K10286484E SERIES SINGLE PLY WRAPPERFRG2011-01-14
2135171102547763K102783HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERSFRG2010-12-22
2135141102547763K102783HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERSFRG2010-12-22
2135151102547763K102783HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERSFRG2010-12-22
2137301924025901K100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALLLYY2010-07-09
2135151659486618K092344LAC-MAC INNERBLOC LR SURGICAL GOWNSFYA2009-12-17
2135171659486618K092344LAC-MAC INNERBLOC LR SURGICAL GOWNSFYA2009-12-17
2135141659486618K092344LAC-MAC INNERBLOC LR SURGICAL GOWNSFYA2009-12-17
2135171308716149K090383SRI LEVEL II SURGICAL GOWNFYA2009-05-29
2135141308716149K090383SRI LEVEL II SURGICAL GOWNFYA2009-05-29
2135151308716149K090383SRI LEVEL II SURGICAL GOWNFYA2009-05-29
2137301792369725K083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGSLZA2009-03-05
2137301160423705K081907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)LYY2008-09-03
2135171135464843K080796SRI LP DRAPEKKX2008-11-17
2135141135464843K080796SRI LP DRAPEKKX2008-11-17
2135151135464843K080796SRI LP DRAPEKKX2008-11-17
2135171222042960K080723SRI LP GOWNFYA2008-11-13
2135141222042960K080723SRI LP GOWNFYA2008-11-13
2135151222042960K080723SRI LP GOWNFYA2008-11-13
2135151148800128K080707SRI PLR GOWNFYA2008-11-13
2135171148800128K080707SRI PLR GOWNFYA2008-11-13
2135141148800128K080707SRI PLR GOWNFYA2008-11-13
2266081288222291K063253RCHIVE PACSLLZ2006-12-12
2135141171233123K061491LAC-MAC INNERBLOC O.R. GOWNFYA2006-08-09
2135151171233123K061491LAC-MAC INNERBLOC O.R. GOWNFYA2006-08-09
2135171171233123K061491LAC-MAC INNERBLOC O.R. GOWNFYA2006-08-09
2135171585462624K041541COMPEL MLR SURGICAL GOWNSFYA2005-03-16
2135151585462624K041541COMPEL MLR SURGICAL GOWNSFYA2005-03-16
2135141585462624K041541COMPEL MLR SURGICAL GOWNSFYA2005-03-16
2135171892775741K031933MEDLINE REUSABLE SURGICAL GOWNS (100X)FYA2003-09-16
2135141892775741K031933MEDLINE REUSABLE SURGICAL GOWNS (100X)FYA2003-09-16
2135151892775741K031933MEDLINE REUSABLE SURGICAL GOWNS (100X)FYA2003-09-16
2135171617875018K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSKKX2003-05-30
2135151617875018K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSKKX2003-05-30
2135141617875018K031362LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALSKKX2003-05-30
2137301672992539K024121NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIMLYY2002-12-20
2137301887479116K024106NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, VITAMIN E AND PROTEIN CLAIMLYY2002-12-20
2137301639863767K021220NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGSLZA2002-06-06
2135171210177805K003755MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPESFYA2001-02-16
2135151210177805K003755MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPESFYA2001-02-16
2135141210177805K003755MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPESFYA2001-02-16
2137301104025709K000329NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILELZA2000-04-05
2135141022793882
2135151022793882
2135181022793882
2135171022793882
2135141042277666
2135171042277666
2135151042277666
2135171223314102
2135151223314102
2135141223314102
3379491521410012
2135171536347519
2135151536347519
2135141536347519
2135171765555762
2135151765555762
2135141765555762
2135172064107830
2135152064107830
2135142064107830

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FYA302009-12-17
LZA152024-07-02
LYY92022-08-09
FRG62011-01-14
KKX62008-11-17
SDT12024-12-23
FMW12016-06-20
LLZ12006-12-12

PMN#

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