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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
Disposable Medical Nitrile Examination Gloves (K223895)Hebei Titans Hongsen Medical Technology Co., Ltd.2023-03-23
Epi-Stop Nasal Gel/epistaxis pack (K230142)Biomed Ent, Inc.2023-03-22
Nitrile Examination Gloves (K222813)Ecoglove Medical Manufacturing Company Limited2023-03-16
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. (K223375)Kossan International Sdn Bhd32023-03-15
Tegamen Nitrile Examination Gloves (K223102)M/S Tegamen Safety Products Private Limited2023-03-15
3D-RD-S (K212587)Radiopharmaceutical Imaging and Dosimetry, LLC2023-02-22
TRAUS Air Dental Handpiece (K221741)Saeshin Precision Co., Ltd.2023-02-22
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (K223298)Shandong Intco Medical Products Co, Ltd.2023-02-22
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X (K220698)Panthera AB2023-02-16
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl (K223859)Rhino Health, Inc.2023-02-13
Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K222129)Top Glove Medical (Thailand) Co., Ltd.2023-02-10
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) (K223559)Nephron Pharmaceuticals Corporation2023-02-09
Powder Free Blue Nitrile Examination Glove (K223444)S&S Glove Corporation2023-02-06
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (K221980)Ever Global (Vietnam) Enterprise Corporation2023-02-06
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) (K223903)Semperit Investments Asia Pte , Ltd.2023-01-27
Omnispec ED1000 (K210166)Medispec, Ltd.2023-01-27
Sterile Surgical Powder Free Latex Glove (K221424)New Era Medicare Sdn. Bhd.2023-01-26
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223415)Mah Sing Healthcare Sdn. Bhd.2023-01-26
Synthetic Polymer Glove - Polyethylene (Black) (K222531)Ur Industry Sdn Bhd2023-01-22
Disposable Nitrile Examination Glove (K223250)Yangzhou Saraguard Medical Supplies Co., Ltd.2023-01-19
Access Testosterone (K223405)Beckman Coulter, Inc.2023-01-13
Non-Sterile Powder Free Nitrile Examination Gloves (K223221)Dynacare Sdn Bhd2023-01-13
Nitrile Exam Gloves (Chemotherapy Drug Tested) (K223748)Us Medical Glove Company, LLC2023-01-13
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate (K222181)Iconic Medicare Sdn Bhd2023-01-11
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K222907)Rmkh Glove (Cambodia) Co., Ltd.2023-01-04
BreathID Hp System (K221896)Meridian Bioscience Israel , Ltd.2022-12-19
Copan FecalSwab Collection, Transport and Preservation System (K220052)Copan Italia Spa2022-12-16
Perceptive electric dental motor and control unit (K220873)Lares Research2022-12-15
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs (K222892)Grand Work Plastic Products Co., Ltd.2022-12-15
Nitrile Patient Examination Glove (K222527)Pingan Medical Products Co., Ltd.2022-12-14
Medidenta High Speed Handpieces (K202674)Pac-Dent, Inc.2022-12-12
Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) (K222733)Inner Mongolia Boming Medical Supplies Co., Ltd.2022-12-11
Disposable Nitrile Examination Glove (K223281)Anhui Kindguard Medical Supplies Technology Co., Ltd.2022-12-07
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate (K221626)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-12-07
Disposable Nitrile Examination Gloves (K223004)Jiangxi Handspro Products Solutions Co., Ltd.2022-12-04
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl (K222815)Zibo Lanhua Medical Packaging Material Co., Ltd.2022-12-04
Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K222715)Safeskin Retailing (Hk) Limited2022-12-03
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K222720)Safeskin Retailing (Hk) Limited2022-12-03
White Nitrile Powder Free Patient Examination Glove, Non Sterile (K222713)Safeskin Retailing (Hk) Limited2022-12-03
Maestro Platform (K221410)Moon Surgical2022-12-02
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs (K221747)Fitone Latex Products Co., Ltd. Guangdong2022-12-01
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (K221082)Rhino Health, Inc.2022-11-30
Powder-Free Latex examination gloves (K222612)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-11-25
Nitrile Patient Examination Glove (K222534)Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd.2022-11-23
Implanter incl. Accessories (K211358)Guilin Woodpecker Medical Instrument Co., Ltd.2022-11-21
Non-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 Fentanyl (K221165)Sri Trang Gloves (Thailand) Public Company Limited2022-11-20
Disposable Urine Collection Tube (K220739)Zhejiang Gongdong Medical Technology Co., Ltd.2022-11-17
FX Contra (K222518)Nakanishi, Inc.2022-11-17
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece (K212910)Shenzhen Carejoy Technology Co., Ltd.2022-11-17
PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326)Hemostasis, LLC2022-11-14
Nitrile Examination Gloves (K213981)Emerald Glove Manufacturing Sdn Bhd2022-11-12
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) (K222225)Hartalega NGC Sdn. Bhd.2022-11-11
BreathID® Smart System (K223185)Meridian Bioscience Israel , Ltd.2022-11-10
Smooth Drive contra angle and straight handpieces (K220874)Lares Research2022-11-07
Lotus Prophy Angle (K220346)Ajk Engineering, Inc.2022-11-07
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (K222898)Safesource Direct, LLC2022-11-07
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220371)Summit Glove, Inc.2022-11-02
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K211816)Brightway Holdings Sdn. Bhd.2022-11-02
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223320)Lingshi Hongruida Health Protection Technology Co., Ltd.2022-11-02
SUPERTILT PLUS (STP) (K221435)Power Plus Mobility2022-10-28
Non Sterile Powder Free Latex Examination Glove (K221667)New Era Medicare Sdn. Bhd.2022-10-28
JR MEDIC (K222348)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-27
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) (K221374)Hebei Titans Hongsen Medical Technology Co., Ltd.2022-10-26
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) (K223235)Pt. Sintong Unigolden Glove2022-10-26
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) (K222498)Humanwell Healthcare Group Medical Supplies Co., Ltd.2022-10-26
JR MEDIC Nitrile Examination Gloves Powder Free- Black (K221169)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-25
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant (K222058)Wrp Asia Pacific Sdn. Bhd.2022-10-22
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) (K222349)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-21
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (K220992)Ever Global (Vietnam) Enterprise Corporation2022-10-19
Infinity Pro, Logic, Quality, Sprint (K213742)Olsen Indústria E Comércio S.A.2022-10-19
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222298)Onetexx Sdn Bhd2022-10-18
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K222721)Safeskin Retailing (Hk) Limited2022-10-18
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves (K222074)Zibo Langu New Material Technology Co., Ltd.2022-10-17
OW100S (model OW100S-US) (K213120)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt2022-10-12
Disposable Vinyl Examination Gloves (K223008)Jiangxi Handspro Products Solutions Co., Ltd.2022-10-08
Infant Heel WarmerTM; Heel Snuggler® (K221154)International Biomedical2022-10-07
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs (K222714)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-10-07
InfaTherm Disposable Infant Warming Mattress (K221653)International Biomedical2022-10-06
Disposable Nitrile Examination Glove (K222937)Jiangsu Cureguard Glove Co., Ltd.2022-10-01
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378)Tec Gloves Industry (M) Sdn.Bhd.2022-09-30
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (K222442)Anhui Bytech Medical Supplies Co., Ltd.2022-09-28
Dental Air Polishing Handpiece (K221548)Guilin Woodpecker Medical Instrument Co., Ltd.2022-09-28
Dental Implantation Systems, Dental Electrical Motors (K220831)Foshan Coxo Medical Instrument Co., Ltd.2022-09-27
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)Hartalega NGC Sdn. Bhd.2022-09-24
Betel Gloves Nitrile Examination Glove Powder Free (K222342)Betel Care Sdn. Bhd.2022-09-24
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid (K222294)Onetexx Sdn Bhd2022-09-24
Single-use medical latex examination gloves (LG100) (K222693)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
Powder Free Nitrile Examination Glove (K212751)Dainam Glove Joint Stock Company2022-09-24
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color (K221887)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-09-24
EQ-M (K210475)Meta Systems Co., Ltd.2022-09-21
Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) (K214056)Mezorrison Medical Technology (Dongying) Co., Ltd.2022-09-20
Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) (K222642)Inner Mongolia Cureguard Medical Technology Co., Ltd.2022-09-20
Pro M Class (K213897)Saeyang Microtech Co., Ltd.2022-09-19
Nitrile Patient Examination Gloves, Powder Free (K220697)Lalan Rubbers (Pvt), Ltd.2022-09-15
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K221748)Guilin Hbm Health Protections, Inc.2022-09-13
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) (K220859)Careglove Global Sdn. Bhd.2022-09-09
EyeCTester (K203594)Neuro-Eye Diagnostic Systems, LLC2022-09-07
Matreneu Percutaneous Balloon Compression Kit (K220920)Shenzhen Shineyard Medical Device Co. , Ltd.2022-09-07
Soteria Bed Barrier (K201876)Trinity Guardion2022-09-01
JR Medic (K221157)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2022-08-30
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Every clearance here is in the API, with alerts when new ones post.