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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
Mar 27, 2008K072403NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
Sgmp Co., Ltd.
LYY
Mar 21, 2008K072406NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
Sgmp Co., Ltd.
LYY
Mar 5, 2008K073299BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
Betel Care Sdn. Bhd., MY
LYY
Feb 29, 2008K072802SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
Ultrawin Sdn Bhd, MY
LYY
Feb 26, 2008K072145MEDICAL GLOVE SERIES
Zhanjiang Jiali Glove Products Co., Ltd., CN
LYY
Nov 19, 2007K072639YUYUAN LATEX EXAMINATION GLOVE, POWDERED
Shandong Yuyuan Latex Gloves Company , Ltd., CN
LYY
Jul 26, 2007K071060NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
Sgmp Co., Ltd.
LYY
Jul 25, 2007K071209MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES
High Momentum Sdn Bhd, MY
LYY
Jul 13, 2007K071322POWDER FREE LATEX EXAMINATION GLOVES
Quality Gallant Sdn. Bhd., MY
LYY
Jun 22, 2007K071323POWDERED LATEX EXAMINATION GLOVES
Quality Gallant Sdn. Bhd., MY
LYY
Jun 7, 2007K070760POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
Derma Care Plus Products, LLC
LYY
May 10, 2007K070821POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
Medtexx Manufacturing Sdn. Bhd., MY
LYY
Apr 13, 2007K062526BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
Multisafe Sdn. Bhd., MY
LYY
Mar 15, 2007K070072NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
Medtexx Manufacturing Sdn. Bhd., MY
LYY
Mar 15, 2007K063581SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
Pt Mahakarya Inti Buana, ID
LYY
Mar 2, 2007K063776ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
Bright Element Sdn Bhd, MY
LYY
Feb 20, 2007K062527BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Multisafe Sdn. Bhd., MY
LYY
Dec 22, 2006K062965CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
Kossan Latex Industries(M)Sdn Bhd
LYY
Dec 6, 2006K062709POWDER FREE LATEX EXAMINATION GLOVES, BLACK
Pt. Maja Agung Latexindo
LYY
Nov 30, 2006K062688POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
Ug Healthcare (Usa), Inc.
LYY
Nov 30, 2006K062313SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
Pt Mahakarya Inti Buana, ID
LYY
Nov 9, 2006K062955POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
Pt. Haloni Jane
LYY
Nov 3, 2006K061233SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
Pt Mahakarya Inti Buana, ID
LYY
Nov 2, 2006K062917STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50
Wear Safe Malaysia Sdn. Bhd., MY
LYY
Aug 24, 2006K061551POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
Medipure Corporation (M) Sdn. Bhd., MY
LYY
Jun 8, 2006K060858LATEX POWDERED EXAMINATION GLOVE
High Momentum Sdn Bhd, MY
LYY
Jun 2, 2006K053305SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
Pt Mahakarya Inti Buana, ID
LYY
May 19, 2006K061078BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
Bright Element Sdn Bhd, MY
LYY
May 16, 2006K060775POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
Kossan Latex Industries(M)Sdn Bhd, MY
LYY
Apr 10, 2006K060658BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
Brightway Holdings Sdn. Bhd., MY
LYY
Mar 15, 2006K060229POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
Shun Thai Rubber Gloves Industry Public Co., Ltd.
LYY
Jan 25, 2006K052666NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN
Ascend Eagle, Inc.
LYY
Dec 6, 2005K050526POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
Spi Gloves Sdn. Bhd., MY
LYY
Dec 5, 2005K052728POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
M/S. Kanam Latex Industries Pvt. , Ltd., IN
LYY
Nov 8, 2005K052709POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
Pt.Shamrock Manufacturing Corp.
LYY
Oct 6, 2005K051987FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
Pt. Mandiri Inti Buana, ID
LYY
Sep 30, 2005K052273POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
Pt Mahakarya Inti Buana, ID
LYY
Sep 30, 2005K051913POWDERED LATEX PATIENT EXAMINATION GLOVES
Shinemound Enterprise, Inc.
LYY
Sep 27, 2005K051404B-CARE POWDER FREE LATEX EXAMINATION GLOVES
B-Care Industries Co., Ltd., TH
LYY
Sep 13, 2005K052214PRE-POWDERED STERILE EXAM GLOVES
Kanam Latex Industries Pvt. , Ltd., IN
LYY
Sep 1, 2005K052016NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
Sgmp Co., Ltd.
LYY
Jul 19, 2005K051329STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
Siam Sempermed Corp., Ltd.
LYY
Jul 12, 2005K051465POWDERED LATEX PATIENT EXAMINATION GLOVES
P.T. Anlis Abadi Internasional
LYY
Jun 23, 2005K051345COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
Glovco (M) Sdn. Bhd., MY
LYY
Jun 7, 2005K050277CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
Hartalega Sdn Bhd, MY
LYY
Apr 14, 2005K050532CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA
Spi Gloves Sdn. Bhd., MY
LYY
Mar 18, 2005K050527POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
Spi Gloves Sdn. Bhd., MY
LYY
Mar 16, 2005K050529POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
Spi Gloves Sdn. Bhd., MY
LYY
Feb 7, 2005K050152PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
Dipped Products (Thailand), Ltd.
LYY
Jan 28, 2005K043014POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)
Shijiazhuang Tillotson Rubber Products Co., Ltd.
LYY

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