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

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RecordFirmDate
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors (K211455)Shen Wei USA, Inc.2021-07-28
Disposable Vinyl Nitrile Synthetic Gloves Powder Free (K211262)Tangshan Hongyun Healthcare Products Co., Ltd.2021-07-24
Nitrile Patient Examination Gloves (K211012)Huayuan Medical Technology(Shangqiu) Co., Ltd.2021-07-23
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs (K211220)Guangdong Kingfa Sci. & Tech.Co., Ltd.2021-07-22
Nitrile Patient Examination Glove (K210686)Yunnan Huazhiyuan Medical Technology Co., Ltd.2021-07-21
Disposable Nitrile Medical Examination Glove (K210684)Jiangsu Cureguard Glove Co., Ltd.2021-07-20
Vinyl Patient Examination Gloves (K211239)Jiangxi Shengda Medical Technology Co., Ltd.2021-07-17
Powder Free Vinyl Patient Examination Gloves (K211177)Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.2021-07-17
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K211547)Edma Group, LLC2021-07-15
Nitrile Patient Examination Glove (K210723)Jiangxi Zhonghong Pulin Medical Products Co., Ltd.2021-07-12
Nitrile Examination Gloves (K210776)5r Med Instruments (Chengdu) Co., Ltd.2021-07-12
Medical Nitrile Examination Gloves (Power free, Blue) (K210578)Jiangxi Hongda Medical Equipment Group , Ltd.2021-07-10
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs (K200915)Gx Corporation Sdn Bhd2021-07-09
Medical PVC Examination Gloves (K210821)Jiangxi Hongda Medical Equipment Group , Ltd.2021-07-09
SensiTox C. difficile Toxin Test (K193490)First Light Diagnostics, Inc.2021-07-08
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K210587)Onetexx Sdn Bhd2021-06-28
White Nitrile Powder Free Patient Examination Glove, Non Sterile (K210775)Onetexx Sdn Bhd2021-06-28
Nitrile Glove (K211252)Jiangsu Dihong Industry and Trade Co., Ltd.2021-06-25
ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs (K210656)Careplus (M) Sdn Bhd2021-06-24
Powder Free Black Nitrile Examination Glove (K201428)Vietglove Corporation2021-06-24
Synthetic Vinyl Examination Gloves (K211045)Jiangsu Huayuan Medical Technology Co., Ltd.2021-06-23
Powder Free Blue Nitrile Examination Glove (K210375)Duramitt Sdn Bhd2021-06-21
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green (K202085)Shen Wei USA, Inc.2021-06-21
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) (K211310)Megine Industries Sdn Bhd2021-06-16
Disposable Vinyl Examination Glove (K211336)Inner Mongolia Cureguard Medical Materials Co., Ltd.2021-06-16
Manual Wheelchair (Model W28) (K200466)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.2021-06-14
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K210401)Ansell Healthcare Products, LLC2021-06-13
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K203030)Wrp Asia Pacific Sdn. Bhd.2021-06-11
Disposable Vinyl Examination Gloves (K210522)Shandong Shengshixincheng Medical Science & Technology Co.,2021-06-10
Nitrile Patient Examination Gloves (K211028)Huayuan Medical Technology(Shangqiu) Co., Ltd.2021-06-04
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs (K202765)Careplus (M) Sdn Bhd2021-05-27
Disposable Synthetic Examination Gloves (K210520)Shandong Shengshixincheng Medical Science & Technology Co.,2021-05-26
Manual Wheelchair, Model A011 (K201461)Ningbo Shenyu Medical Equipment Co.,Ltd2021-05-21
Impla-NX (Model: ISE-270M) (K201192)Micro-Nx Co., Ltd.2021-05-21
ATS 5000 Automatic Tourniquet Instrument (K202919)Mcewen and Associates Consulting , Ltd.2021-05-20
Disposable Latex Powder Free Examination Gloves (Non-sterile) (K201576)Pt. Universal Gloves2021-05-19
NitriTec Vinyl Glove Powder Free Blue (K210460)Zhonghong Pulin Medical Products Co., Ltd.2021-05-17
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210774)Shandong Jieshi Medical Products Co., Ltd.2021-05-14
Powder Free Vinyl Patient Examination Gloves (K210799)Yunnan Huazhiyuan Medical Technology Co., Ltd.2021-05-14
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K210780)Shandong Shangwei Medical Products Co., Ltd.2021-05-14
Powder Free Nitrile Examination Glove (K210369)Pastel Glove Sdn Bhd2021-05-13
Single-use medical poly (vinyl chloride) examination glove (K201504)Anhui Bytech Medical Supplies Co., Ltd.2021-05-10
Endo Motor (K203320)Guilin Woodpecker Medical Instrument Co., Ltd.2021-05-10
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K210366)Onetexx Sdn Bhd2021-05-07
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210755)Meditech Gloves Sdn Bhd2021-05-07
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (K203036)Central Medicare Sdn Bhd2021-05-07
OrthoGold 100 (K210451)Tissue Regeneration Technologies, LLC2021-05-05
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (K210944)Harbour Health, LLC2021-04-29
Disposable Nitrile Examination Gloves (K203436)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-04-28
Powder Free Blue Nitrile Examination Glove (K203512)Vip Glove Sdn Bhd2021-04-26
Nitrile Glove Powder Free Blue (K210145)Changzhou Universal Medical Equipment Co., Ltd.2021-04-21
Disposable Nitrile Examination Gloves (K203805)Jiangsu Yanfang Medical Technology Co., Ltd.2021-04-20
Disposable Nitrile Gloves (K210276)Fujian Ercon Medical Management Co., Ltd.2021-04-16
BIOTECH Nitrile Examination Gloves (K202419)Tk Hitech Technology Co., Ltd.2021-04-16
Nitrile Examination Gloves (K210106)Zhenjiang Huayang Latex Products Co., Ltd.2021-04-07
Blue Nitrile Exam Glove, Powder Free (K210057)Real Star Medical Technology Co., Ltd.2021-03-31
Blue Nitrile Exam Glove, Powder Free (K210058)Great Harvest Trading Co., Ltd.2021-03-30
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (K202083)Shen Wei USA, Inc.2021-03-25
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color (K202080)Shen Wei USA, Inc.2021-03-24
Patient Examination Gloves (K203593)Guangdong Kingfa Sci. & Tech.Co., Ltd.2021-03-19
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue (K202081)Shen Wei USA, Inc.2021-03-19
Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid (K202082)Shen Wei USA, Inc.2021-03-17
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors (K202086)Shen Wei USA, Inc.2021-03-16
Vinyl Examination Gloves(Yellow) (K203666)Lutai Medical Technology Co., Ltd.2021-03-12
Endo Motor (K192649)Foshan Cicada Dental Instrument Co, Ltd.2021-03-12
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors (K202076)Shen Wei USA, Inc.2021-03-05
Biodegradable Thermoplastic Elastomer Examination (TPE) Glove (K202078)Shen Wei USA, Inc.2021-03-05
Cultura Collection and Transport System (K201674)Merit Medical Systems, Inc.2021-03-03
Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) (K202356)Kanglongda Vietnam Protection Technology Company Limited2021-03-02
Nitrile Examination Gloves (Blue, Violet Blue, White) (K202402)Jiangsu Tianshuo Medical Products Co., Ltd.2021-03-01
Disposable Vinyl Examination Gloves (K203439)Shandong Zhushi Pharmaceutical Group Co., Ltd.2021-02-26
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (K202003)Gmp Medicare Sdn. Bhd.2021-02-24
PROXEO Twist Cordless Polishing System PL-40 H (K201703)W&H Dentalwerk Buermoos GmbH2021-02-24
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein (K202401)Eco Medi Glove Sdn. Bhd.2021-02-17
Vinyl Examination Gloves (Yellow) (K203702)Xinying Trading Co., Ltd.2021-02-12
LYDUS Nitrile Examination Gloves, Powder Free (K203191)Nathan Trading Co., Ltd.2021-02-12
TRAUS SIP20 (K201292)Saeshin Precision Co., Ltd.2021-02-11
Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (K203483)Guilin Hbm Health Protections, Inc.2021-02-01
E-connect S Endo Motor with built-in Apex Locator (K201993)Changzhou Sifary Medical Technology Co., Ltd.2021-01-29
Polyisoprene Powder Free, Black Colour Surgical Gloves (K192933)Emerson & Co. Srl2021-01-13
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate (K202622)O&M Halyard, Inc.2021-01-07
Thermidas IR System (ThIR-A615) (K200999)Thermidas Americas, Inc.2021-01-06
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein (K202668)Medline Industries, Inc.2020-12-19
Novapak Nasal Sinus Packing and Stent (K202623)Medtronic Xomed2020-12-08
Palm Care Blue Nitrile Examination Gloves Powder Free (K202384)Hi-Care Thai Gloves Co. , Ltd.2020-12-02
Palm Care Latex Examination Powder Free Gloves (K202377)Hi-Care Thai Gloves Co. , Ltd.2020-12-01
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (K202416)Kimberly Clark Corporation2020-11-30
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (K202090)Molnlycke Health Care Us, LLC2020-11-22
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein (K202449)Medline Industries, Inc.2020-11-18
OtoSet- Ear Cleaning System (K201877)Safkan, Inc.2020-11-05
General Cutting Contra Handpiece (K202960)Nakanishi, Inc.2020-10-27
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) (K202179)Medline Industries, Inc.2020-10-26
Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) (K200150)Medline Industries, Inc.2020-10-26
Disposable Vinyl Glove (K202010)Better Health Medical Products Co., Ltd.2020-10-16
LIAISON Testosterone xt (K201908)DiaSorin, Inc.2020-10-15
SINUSPRIME Dilation System (K201398)Stryker Ent2020-10-15
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (K200633)0 & M Halyard, Inc.2020-10-11
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs (K201748)Hartalega Sdn Bhd2020-10-02
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs (K200843)O&M Halyard, Inc.2020-09-22
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) (K201390)Medline Industires, Inc.2020-09-18
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Every clearance here is in the API, with alerts when new ones post.