Atlas FDA

LYY

1,954 FDA 510(k) clearances · Product code

79 daysmedian time to decision
210 days90th percentile
1,954clearances measured

FDA profile

Official device name
Latex Patient Examination Glove
Device class
Class I (low risk)
Regulation
21 CFR 880.6250
Medical specialty
General Hospital
Flags
Third-party review eligible
FDA definition
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Adverse events (MAUDE)
2005: 12 · 2006: 6 · 2007: 11 · 2008: 14 · 2009: 11 · 2010: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein (K250069)Comfort Rubber Gloves Industries Sdn. Bhd.2025-04-29
Latex Examination Glove Powder Free (Ocean Blue and Natural White) (K240266)Sri Trang Gloves (Thailand) Public Company Limited2024-09-09
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) (K230573)Kossan International Sdn Bhd2023-06-13
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (K223298)Shandong Intco Medical Products Co, Ltd.2023-02-22
Powder-Free Latex examination gloves (K222612)Guangdong Kingfa Sci. & Tech.Co., Ltd.2022-11-25
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
Single-use medical latex examination gloves (LG100) (K222693)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
Iconic Latex Glove (K221648)Iconic Medicare Sdn Bhd2022-08-25
Powder Free Latex Examination Glove, Non-Sterile (K211601)Wrp Asia Pacific Sdn. Bhd.2022-08-22
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White (K212482)Sri Trang Gloves (Thailand) Public Company Limited2022-08-09
Examination gloves-Type A(Latex gloves) (K214017)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-07-14
TC Gloves (K221185)Thanh Cong Pharmaceutical and Trading Company Limited2022-06-22
Amazing+ Latex Examination Powder Free Gloves (K212597)Amazing Rubber Products Pvt, Ltd.2022-05-28
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves (K213775)Avecena Gloves Sdn Bhd2022-04-24
Latex Examination Gloves, Powder Free (K213509)Shandong Intco Medical Products Co, Ltd.2022-04-08
Non-sterile, Powder-Free Latex Examination Glove (K212309)Sri Trang Gloves (Thailand) Public Company Limited2022-04-08
Goody Gloves, Wincare, TBG Gloves (K213073)Thai Rubber Gloves Co., Ltd.2021-12-29
Comfortpro (K212438)Thai Rubber Industry Company Limited2021-12-07
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) (K203074)Pt. Universal Gloves2021-11-19
Best Glove-Latex Powder Free Examination Glove (K210253)Bestsafe Glove Co., Ltd.2021-11-05
Latex Examination Powder Free Gloves (K211477)Aspen Glove Sdn. Bhd.2021-09-20
Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) (K203705)Careplus (M) Sdn Bhd2021-08-20
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) (K211620)Shen Wei USA, Inc.2021-08-19
Disposable Latex Powder Free Examination Gloves (Non-sterile) (K201576)Pt. Universal Gloves2021-05-19
Palm Care Latex Examination Powder Free Gloves (K202377)Hi-Care Thai Gloves Co. , Ltd.2020-12-01
Blue Latex Examination Powder Free Gloves (K192329)Jr Engineering & Medical Technologies (M) Sdn. Bhd.2019-11-25
POWDER FREE LATEX EXAMINATION GLOVE (K173053)Professional Latex Sdn Bhd2018-06-06
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) (K171367)Sanrea Healthcare Products Pvt, Ltd.2018-01-26
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED (K170094)Vietglove Corporation2017-06-23
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein (K170779)Terang Nusa Sdn Bhd2017-05-24
LATEX EXAMINATION GLOVE POWDER FREE (K161833)Careglove Global Sdn. Bhd.2017-05-23
UniTex Non-Sterile, Powder-Free, Latex Examination Glove (K161961)Ug Global Resources Sdn. Bhd.2017-05-11
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less (K162175)Vietglove Corporation2016-11-21
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove (K161006)Hartalega Sdn Bhd2016-08-04
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) (K153744)A1 Glove Sdn Bhd2016-08-04
LATEX EXAMINATION GLOVE POWDER FREE (K152593)Careplus (M) Sdn Bhd2016-02-25
Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) (K150612)Anhui Anyu Latex Products Co., Ltd.2015-11-16
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES (K141042)Mercator Medical (Thailand), Ltd.2015-03-19
Patient Examination Gloves (K143419)Hartalega NGC Sdn. Bhd.2015-03-06
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE (K142270)Hartalega Sdb. Bhd.2014-11-25
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M (K133953)Hartalega Sdn Bhd2014-05-28
POWDER FREE LATEX EXAMINATION GLOVES (K123537)Qube Medical Product Sdn Bhd2014-02-12
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K121844)Worldmed Manufacturing Sdn. Bhd.2013-09-06
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL (K130667)Preventive Care, Inc.2013-07-24
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT (K123368)Hartalega Sdn Bhd2013-05-07
MULTIPLE NAME (K123819)Top Calibre Sdn Bhd2013-03-05
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR (K123757)Assurguard Sdn. Bhd.2013-02-01
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O (K122788)Northstar Healthcare Holdings2013-01-17
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO (K123026)Northstar Healthcare Holdings2012-11-16
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE) (K121594)Tekmedic (M) Sdn Bhd2012-10-25
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) (K121591)Tekmedic (M) Sdn Bhd2012-10-11
NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES (K112693)Sgmp Co., Ltd.2012-09-12
POWDER FREE LATEX EXAMINATION GLOVES (K113685)Khai Hoan Joint Stock Company2012-08-10
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES (K120963)Medtexx Manufacturing Sdn. Bhd.2012-06-29
LANO-E (K111604)Ug Global Resources Sdn. Bhd.2012-06-08
LATEX EXAMINATION GLOVES (POWDER FREE) (K120692)Top Calibre Sdn Bhd2012-05-14
LATEX EXAMINATION GLOVES (POWDERED) (K120693)Top Calibre Sdn Bhd2012-05-08
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K112005)Ug Healthcare (Usa), Inc.2012-03-21
POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (K112612)Top Calibre Sdn Bhd2012-01-18
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE (K112988)Northstar Healthcare Holdings Limited2011-11-09
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K111923)Pt. Intan Hevea Industry2011-11-04
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES (K110250)Total Gloves Sdn Bhd2011-10-14
LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K111158)Innovative Gloves Co;, Ltd.2011-08-10
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS) (K111133)Ssc Surat Thani2011-06-24
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) (K100895)Dipped Products Limited2011-05-27
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR (K102902)Rubbercare Protection Products Sdn Bhd2011-04-22
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM (K103602)Medline Industries, Inc.2011-04-21
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM (K103650)Oon Corp. Resources2011-03-23
PATIENT EXAMINATION GLOES (K102840)Thai Hua Holding Co., Ltd.2011-02-18
PATIENT EXAMINATION GLOVES (K102838)Thai Hua Holding Co., Ltd.2011-02-03
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 (K101106)Best Putra Gloves Sdn Bhd2010-11-10
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 (K101105)Best Putra Gloves Sdn Bhd2010-11-10
COMFORT RUBBER GLOVES IND.SDN.BHD. (K101917)Comfort Rubber Gloves Industries Sdn. Bhd.2010-10-29
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K101828)Gx Corporation Sdn Bhd2010-10-04
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE (K101799)Wear Safe (Malaysia) Sdn. Bhd.2010-09-03
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF (K101645)Latexx Manufacturing Sdn.Bhd.2010-08-26
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) (K100611)Riverstone Resources Sdn Bhd2010-07-16
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL (K100907)Siam Sempermed Corp., Ltd.2010-07-09
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN (K100694)Tekmedic (M) Sdn Bhd2010-06-25
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) (K093193)La Glove (M) Sdn. Bhd.2010-06-08
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA (K100211)Shen Wei (Usa), Inc.2010-05-11
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K092681)Khai Hoan Joint Stock Company2010-02-23
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT (K093496)Oon Corp. Resources2010-02-03
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS) (K093375)Koon Seng Sdn Bhd2009-12-02
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) (K092499)La Glove (M) Sdn. Bhd.2009-11-20
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O (K092492)Wear Safe (Malaysia) Sdn. Bhd.2009-10-21
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR (K083571)Purna Bina Sdn Bhd2009-08-13
ALATECH POWDER FREE LATEX EXAMINATION GLOVE (K083761)Alatech Healthcare, LLC2009-07-22
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE (K090327)Wear Safe (Malaysia) Sdn. Bhd.2009-04-03
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES (K083337)Terang Nusa Sdn Bhd2009-01-27
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE (K081910)Siam Sempermed Corp., Ltd.2008-09-17
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) (K081907)Siam Sempermed Corp., Ltd.2008-09-03
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K081488)Pt. Maja Agung Latexindo2008-08-28
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES (K081464)Cardinalhealth2008-08-28
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE (K080606)Alatech Healthcare, LLC2008-08-07
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE (K081040)Pt.Shamrock Manufacturing Corp.2008-05-20
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (K072300)Perusahaan Pelindung Getah (M) Sdn Bhd2008-05-16
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE (K072614)Matang Mfg. Sdn. Bhd.2008-04-15
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