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Panels › General Hospital › Product code LYY · Class 1

Latex Patient Examination Glove

Regulation 880.6250

0510(k)s in 12 months (1,954 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
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Top companies in LYY

Company510(k)sRecalls
Wembley Rubber Products (M) Sdn Bhd370
Sgmp Co., Ltd.250
Hartalega Sdn Bhd190
Siam Sempermed Corp., Ltd.190
Perusahaan Getah Asas Sdn. Bhd.160
Pamitex Industries Sdn Bhd150
Shield Gloves Manufacturer (M) Sdn Bhd150
Aladan Corp.140
Shen Wei (Usa), Inc.140
Sri Johani Sdn. Bhd.140
Decided510(k)Device and applicantCode
Apr 29, 2025K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Le
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LYY
Sep 9, 2024K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Sri Trang Gloves (Thailand) Public Company Limited, TH
LYY
Jun 13, 2023K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 5
Kossan International Sdn Bhd, MY
LYY
Feb 22, 2023K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Shandong Intco Medical Products Co, Ltd., CN
LYY
Nov 25, 2022K222612Powder-Free Latex examination gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LYY
Oct 28, 2022K221667Non Sterile Powder Free Latex Examination Glove
New Era Medicare Sdn. Bhd., MY
LYY
Oct 27, 2022K222348JR MEDIC
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LYY
Oct 26, 2022K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Technology Co., Ltd., CN
LYY
Sep 24, 2022K222693Single-use medical latex examination gloves (LG100)
Fitone Latex Products Co., Ltd. Guangdong, CN
LYY
Aug 25, 2022K221648Iconic Latex Glove
Iconic Medicare Sdn Bhd, MY
LYY
Aug 22, 2022K211601Powder Free Latex Examination Glove, Non-Sterile
Wrp Asia Pacific Sdn. Bhd., MY
LYY
Aug 9, 2022K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Sri Trang Gloves (Thailand) Public Company Limited, TH
LYY
Jul 14, 2022K214017Examination gloves-Type A(Latex gloves)
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., CN
LYY
Jun 22, 2022K221185TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited, VN
LYY
May 28, 2022K212597Amazing+ Latex Examination Powder Free Gloves
Amazing Rubber Products Pvt, Ltd., IN
LYY
Apr 24, 2022K213775Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Avecena Gloves Sdn Bhd, MY
LYY
Apr 8, 2022K213509Latex Examination Gloves, Powder Free
Shandong Intco Medical Products Co, Ltd., CN
LYY
Apr 8, 2022K212309Non-sterile, Powder-Free Latex Examination Glove
Sri Trang Gloves (Thailand) Public Company Limited, TH
LYY
Dec 29, 2021K213073Goody Gloves, Wincare, TBG Gloves
Thai Rubber Gloves Co., Ltd., TH
LYY
Dec 7, 2021K212438Comfortpro
Thai Rubber Industry Company Limited, TH
LYY
Nov 19, 2021K203074Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
Pt. Universal Gloves, ID
LYY
Nov 5, 2021K210253Best Glove-Latex Powder Free Examination Glove
Bestsafe Glove Co., Ltd., TH
LYY
Sep 20, 2021K211477Latex Examination Powder Free Gloves
Aspen Glove Sdn. Bhd., MY
LYY
Aug 20, 2021K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
Careplus (M) Sdn Bhd, MY
LYY
Aug 19, 2021K211620Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling c
Shen Wei USA, Inc.
LYY
May 19, 2021K201576Disposable Latex Powder Free Examination Gloves (Non-sterile)
Pt. Universal Gloves, ID
LYY
Dec 1, 2020K202377Palm Care Latex Examination Powder Free Gloves
Hi-Care Thai Gloves Co. , Ltd., TH
LYY
Nov 25, 2019K192329Blue Latex Examination Powder Free Gloves
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LYY
Jun 6, 2018K173053POWDER FREE LATEX EXAMINATION GLOVE
Professional Latex Sdn Bhd, MY
LYY
Jan 26, 2018K171367SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Sanrea Healthcare Products Pvt, Ltd., IN
LYY
Jun 23, 2017K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
Vietglove Corporation, VN
LYY
May 24, 2017K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable pr
Terang Nusa Sdn Bhd, MY
LYY
May 23, 2017K161833LATEX EXAMINATION GLOVE POWDER FREE
Careglove Global Sdn. Bhd., MY
LYY
May 11, 2017K161961UniTex Non-Sterile, Powder-Free, Latex Examination Glove
Ug Global Resources Sdn. Bhd., MY
LYY
Nov 21, 2016K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Vietglove Corporation, VN
LYY
Aug 4, 2016K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Hartalega Sdn Bhd, MY
LYY
Aug 4, 2016K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm
A1 Glove Sdn Bhd, MY
LYY
Feb 25, 2016K152593LATEX EXAMINATION GLOVE POWDER FREE
Careplus (M) Sdn Bhd, MY
LYY
Nov 16, 2015K150612Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and
Anhui Anyu Latex Products Co., Ltd., CN
LYY
Mar 19, 2015K141042MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
Mercator Medical (Thailand), Ltd.
LYY
Mar 6, 2015K143419Patient Examination Gloves
Hartalega NGC Sdn. Bhd., MY
LYY
Nov 25, 2014K142270LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
Hartalega Sdb. Bhd., MY
LYY
May 28, 2014K133953LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
Hartalega Sdn Bhd, MY
LYY
Feb 12, 2014K123537POWDER FREE LATEX EXAMINATION GLOVES
Qube Medical Product Sdn Bhd, MY
LYY
Sep 6, 2013K121844POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
Worldmed Manufacturing Sdn. Bhd., MY
LYY
Jul 24, 2013K130667POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
Preventive Care, Inc.
LYY
May 7, 2013K123368LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
Hartalega Sdn Bhd, MY
LYY
Mar 5, 2013K123819MULTIPLE NAME
Top Calibre Sdn Bhd, MY
LYY
Feb 1, 2013K123757POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
Assurguard Sdn. Bhd., MY
LYY
Jan 17, 2013K122788TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
Northstar Healthcare Holdings, IE
LYY

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