{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "third_party_flag": "Y", "life_sustain_support_flag": "N", "gmp_exempt_flag": "N", "summary_malfunction_reporting": "Eligible", "product_code": "KGO", "openfda": { "k_number": [ "K811753", "K151114", "K192988", "K202668", "K882595", "K892064", "K924071", "K171375", "K872996", "K991205", "K221748", "K130301", "K053406", "K013603", "K142992", "K984512", "K980880", "K884499", "K913207", "K982589", "K962986", "K895018", "K972277", "K212848", "K974783", "K151778", "K943674", "K962539", "K885271", "K903534", "K053442", "K011721", "K904769", "K980929", "K923576", "K935870", "K981096", "K895603", "K943254", "K884425", "K023912", "K022442", "K971381", "K984064", "K971945", "K883736", "K760560", "K052030", "K982613", "K992020", "K130450", "K823086", "K000896", "K954325", "K943566", "K904662", "K932061", "K032467", "K201829", "K895823", "K051563", "K892495", "K113707", "K182948", "K001047", "K921804", "K222350", "K974356", "K945157", "K190018", "K955419", "K880632", "K954535", "K014283", "K171047", "K894828", "K032647", "K232444", "K032501", "K911134", "K895230", "K812735", "K980942", "K951662", "K003769", "K760912", "K170198", "K892056", "K904361", "K021598", "K833093", "K992219", "K922979", "K964440", "K202401", "K900296", "K983962", "K014278", "K791843", "K820665", "K222620", "K053272", "K062950", "K160928", "K920745", "K213289", "K884495", "K230304", "K935464", "K043508", "K895669", "K802027", "K071746", "K973699", "K033564", "K902449", "K221424", "K191898", "K202449", "K864521", "K925030", "K905012", "K071565", "K171987", "K892108", "K031301", "K171550", "K843125", "K230832", "K002593", "K913215", "K211953", "K894010", "K112257", "K140477", "K193217", "K893340", "K912797", "K932664", "K033905", "K071700", "K012104", "K071414", "K222993", "K903987", "K180221", "K992171", "K903446", "K954462", "K010862", "K052177", "K884328", "K943255", "K232079", "K896675", "K890289", "K131751", "K895027", "K950185", "K972009", "K883466", "K900669", "K030444", "K191869", "K001343", "K951661", "K101811", "K021119", "K161823", "K151605", "K190782", "K062847", "K945833", "K111878", "K221718", "K141719", "K173258", "K914445", "K885089", "K910928", "K880480", "K181047", "K884882", "K201774", "K000295", "K935227", "K892061", "K142941", "K111807", "K102500", "K003771", "K140988", "K210656", "K151392", "K901359", "K030445", "K880446", "K122557", "K896432", "K151228", "K910895", "K963020", "K891621", "K053102", "K201748", "K893834", "K010438", "K993349", "K953015", "K110698", "K874539", "K813088", "K963218", "K970795", "K980564", "K991940", "K991950", "K884030", "K211621", "K172942", "K993215", "K903069", "K151694", "K900298", "K020308", "K890073", "K020918", "K000971", "K895448", "K070619", "K012479", "K970160", "K032464", "K954049", "K022873", "K900587", "K112089", "K190632", "K203483", "K230217", "K150973", "K883556", "K802641", "K000178", "K222058", "K912478", "K844236", "K922116", "K110272", "K992021", "K892899", "K042534", "K911268", "K923929", "K960178", "K002192", "K893899", "K983489", "K050184", "K003895", "K992679", "K050899", "K940797", "K881821", "K153316", "K992019", "K023236", "K042574", "K881374", "K770056", "K993201", "K012135", "K891404", "K981392", "K010439", "K240790", "K121925", "K993562", "K880535", "K053443", "K210724", "K914097", "K010198", "K012819", "K041436", "K231902", "K954025", "K840343", "K111413", "K210969", "K861441", "K021065", "K915218", "K051562", "K190077", "K111139", "K013560", "K000421", "K850635", "K950468", "K052031", "K894928", "K063582", "K930794", "K982586", "K200897", "K980516", "K192933", "K193573", "K935869", "K001959", "K081180", "K896051", "K922769", "K050533", "K170152", "K760248", "K904244", "K001239", "K894087", "K160781", "K183536", "K920876", "K173304", "K160974", "K891622", "K962837", "K024130", "K151607", "K945948", "K063757", "K062797", "K883244", "K884622", "K101103", "K021784", "K964962", "K111868", "K012067", "K933062", "K904972", "K102177", "K051793", "K984337", "K052837", "K881756", "K896165", "K013302", "K023139", "K011066", "K881191", "K781847", "K182176", "K150146", "K992018", "K191915", "K191860", "K991939", "K912157", "K123628", "K905624", "K020019", "K192820", "K914824", "K992752", "K023515", "K231446", "K941770", "K780419", "K905537", "K993857", "K150238", "K032942", "K150609", "K770704", "K071465", "K831565", "K003019", "K991949", "K014230", "K971471", "K964474", "K964980", "K230578", "K112654", "K161008", "K962724", "K882639", "K051094", "K953641", "K944053", "K192328", "K891308", "K960416", "K171279", "K001049", "K050181", "K203030", "K894034", "K000179", "K001924", "K214074", "K982600", "K925861", "K890311", "K123126", "K953639", "K103714", "K904320", "K070647", "K211478", "K982957", "K896327", "K961632", "K003063", "K902831", "K864165", "K993450", "K900985", "K990710", "K913402", "K902714", "K951908", "K897192", "K121897", "K231973", "K980412", "K121335", "K170515", "K882715", "K760243", "K911245", "K013914", "K991992", "K940218", "K061038", "K882392", "K800152", "K984395", "K983982", "K013727", "K012896", "K013604", "K842884", "K951473", "K212596", "K993756", "K945505", "K874099", "K090066", "K880035", "K892285", "K012880", "K052772", "K002933", "K092304", "K160875", "K140355", "K140989", "K992953", "K042567", "K011446", "K812421", "K171898", "K173386", "K983240", "K984559", "K202765", "K030228", "K101102", "K973461", "K833976", "K162852", "K073447", "K993214", "K172420", "K113233", "K910711", "K202090", "K111015", "K962813", "K991317", "K952993", "K053441", "K021159", "K894501", "K041437", "K882200", "K913893", "K984066", "K945363", "K953712", "K882431", "K201592", "K102119", "K031670", "K890459", "K031368", "K903212", "K945158", "K200915", "K953358", "K960407", "K932665", "K905161", "K981947", "K954002", "K901398", "K994081", "K884633", "K892499", "K813565", "K031130", "K875349", "K230079", "K060030", "K984558", "K892922", "K892176", "K832448", "K123629", "K014288", "K972621", "K881069", "K760811", "K183389", "K882381", "K915086", "K040503", "K910383", "K922515", "K190241", "K031669", "K120934", "K171276", "K864064", "K132802", "K894354", "K881664", "K921664", "K894073", "K883824", "K894256", "K050071", "K203538", "K152428", "K902380", "K250313", "K001274", "K142190", "K013324", "K093300", "K101163", "K831632", "K903513", "K022444", "K970924", "K915807" ], "registration_number": [ "", "8040980", "3010436932", "3007048057", "3029901632", "3012441043", "3008253024", "3009337401", "3011088743", "1833700", "3043051314", "2648727", "9615914", "3021192208", "3014421917", "1649518", "3010966951", "3010131137", "3012304897", "3016785252", "3016761372", "1055236", "2032112", "3015997711", "1061124", "9611959", "9614502", "8041180", "1018470", "3009229300", "3005187671", "8041003", "3012104670", "3004681601", "3021915797", "3004450493", "3005022483", "3010273867", "3014269027", "3010309112", "8041150", "3012341425", "3013557562", "3015173212", "3034669683", "9616088", "1423537", "3013516822", "3009538921", "3027157158", "3004967282", "3001124136", "3017616393", "3004111573", "3003744503", "2939388", "3010175289", "3012551999", "9680794", "3030733800", "1043214", "3025355668", "3003529075", "2029015", "3002806603", "3012050423", "3010605427", "3014164734", "2024351", "9613910", "1417592", "3020521811", "1643817", "3007344957", "3024374107", "3019769825", "9680622", "3003199637", "3013298431", "8043736", "1921846", "3007478974", "3013530281", "9617444", "8040614", "3023339256", "8043142", "3010187826", "3023143119", "9616501", "3008252486", "3042894943", "3026317063", "3012354669", "3010419931", "3012307300", "3013517171", "8022899", "3012421607", "3014579161", "3003699698", "3008266585", "3016413634", "3011689956", "3043226252", "3010220595", "3010602489", "9610406", "3018507299", "3011200663", "3011944170", "3001970230", "9680710", "3011209798", "8041005", "1319639", "3006552561", "3007289408", "9610054", "8040818", "2026990", "3008062466", "1054241", "3012494290", "3025413681", "9613662", "3030172764", "3006796582", "3035455506", "3018299689", "3024706752", "3014384460", "9615978", "3016904853" ], "fei_number": [ "", "3010436932", "3007048057", "3002955419", "3029901632", "3012441043", "3008253024", "3009337401", "3011088743", "3043051314", "2648727", "3021192208", "3014421917", "3010966951", "1000160458", "3010131137", "3012304897", "3016785252", "3016761372", "3002808252", "3015997711", "1018470", "3009229300", "3005187671", "3012104670", "3004681601", "3021915797", "3004450493", "3005022483", "3010273867", "3014269027", "3010309112", "3012341425", "3002808366", "3013557562", "3015173212", "3332", "3001236905", "3034669683", "3003221560", "3013516822", "3009538921", "3027157158", "3004967282", "3001124136", "3017616393", "3003189428", "3004111573", "3003744503", "2939388", "3010175289", "3012551999", "3030733800", "1043214", "3025355668", "3004621557", "3003529075", "3002806603", "3012050423", "3014164734", "3010605427", "2024351", "1417592", "3020521811", "1643817", "3166", "1000112968", "1000154563", "3007344957", "3002806389", "3002806370", "3024374107", "3019769825", "3003199637", "3013298431", "1921846", "3003076831", "3007478974", "1000207790", "3013530281", "1000112877", "3001236277", "3003045222", "3023339256", "3003737899", "1000138054", "3010187826", "3023143119", "3008252486", "3042894943", "3002919051", "3002808507", "3009157666", "3026317063", "3012354669", "3010419931", "3012307300", "3013517171", "3012421607", "3014579161", "3003699698", "3008266585", "3016413634", "3011689956", "3043226252", "3010220595", "3010602489", "3018507299", "3011200663", "3011944170", "3001970230", "3011209798", "1000512168", "3002677549", "3006552561", "1000153304", "3000239897", "3007289408", "2026990", "3008062466", "3004574120", "3012494290", "3025413681", "1000115586", "3030172764", "3006796582", "3035455506", "3018299689", "3002807146", "3024706752", "3004048089", "3014384460", "3002902735", "3016904853" ] }, "review_panel": "HO", "medical_specialty": "SU", "device_name": "Surgeon'S Gloves", "review_code": "", "unclassified_reason": "", "medical_specialty_description": "General, Plastic Surgery", "device_class": "1", "definition": "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.", "regulation_number": "878.4460", "implant_flag": "N", "submission_type_id": "1" } ] }