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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
Nov 16, 2012K123026TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
Northstar Healthcare Holdings, BM
LYY
Oct 25, 2012K121594COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
Tekmedic (M) Sdn Bhd, MY
LYY
Oct 11, 2012K121591FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
Tekmedic (M) Sdn Bhd, MY
LYY
Sep 12, 2012K112693NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
Sgmp Co., Ltd.
LYY
Aug 10, 2012K113685POWDER FREE LATEX EXAMINATION GLOVES
Khai Hoan Joint Stock Company, VN
LYY
Jun 29, 2012K120963POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
Medtexx Manufacturing Sdn. Bhd., MY
LYY
Jun 8, 2012K111604LANO-E
Ug Global Resources Sdn. Bhd.
LYY
May 14, 2012K120692LATEX EXAMINATION GLOVES (POWDER FREE)
Top Calibre Sdn Bhd, MY
LYY
May 8, 2012K120693LATEX EXAMINATION GLOVES (POWDERED)
Top Calibre Sdn Bhd, MY
LYY
Mar 21, 2012K112005NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Ug Healthcare (Usa), Inc.
LYY
Jan 18, 2012K112612POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
Top Calibre Sdn Bhd, MY
LYY
Nov 9, 2011K112988POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
Northstar Healthcare Holdings Limited
LYY
Nov 4, 2011K111923SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Pt. Intan Hevea Industry, ID
LYY
Oct 14, 2011K110250MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
Total Gloves Sdn Bhd, MY
LYY
Aug 10, 2011K111158LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Innovative Gloves Co;, Ltd., TH
LYY
Jun 24, 2011K111133NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
Ssc Surat Thani
LYY
May 27, 2011K100895PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
Dipped Products Limited, LK
LYY
Apr 22, 2011K102902RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
Rubbercare Protection Products Sdn Bhd, MY
LYY
Apr 21, 2011K103602EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
Medline Industries, Inc.
LYY
Mar 23, 2011K103650NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
Oon Corp. Resources
LYY
Feb 18, 2011K102840PATIENT EXAMINATION GLOES
Thai Hua Holding Co., Ltd.
LYY
Feb 3, 2011K102838PATIENT EXAMINATION GLOVES
Thai Hua Holding Co., Ltd.
LYY
Nov 10, 2010K101106POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
Best Putra Gloves Sdn Bhd, MY
LYY
Nov 10, 2010K101105POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
Best Putra Gloves Sdn Bhd, MY
LYY
Oct 29, 2010K101917COMFORT RUBBER GLOVES IND.SDN.BHD.
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LYY
Oct 4, 2010K101828POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Gx Corporation Sdn Bhd, MY
LYY
Sep 3, 2010K101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
Wear Safe (Malaysia) Sdn. Bhd., MY
LYY
Aug 26, 2010K101645NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
Latexx Manufacturing Sdn.Bhd., MY
LYY
Jul 16, 2010K100611RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
Riverstone Resources Sdn Bhd, MY
LYY
Jul 9, 2010K100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
Siam Sempermed Corp., Ltd.
LYY
Jun 25, 2010K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
Tekmedic (M) Sdn Bhd, MY
LYY
Jun 8, 2010K093193LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
La Glove (M) Sdn. Bhd., MY
LYY
May 11, 2010K100211PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
Shen Wei (Usa), Inc.
LYY
Feb 23, 2010K092681POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
Khai Hoan Joint Stock Company, VN
LYY
Feb 3, 2010K093496NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT
Oon Corp. Resources
LYY
Dec 2, 2009K093375KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
Koon Seng Sdn Bhd
LYY
Nov 20, 2009K092499LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
La Glove (M) Sdn. Bhd., MY
LYY
Oct 21, 2009K092492POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
Wear Safe (Malaysia) Sdn. Bhd., MY
LYY
Aug 13, 2009K083571ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
Purna Bina Sdn Bhd, MY
LYY
Jul 22, 2009K083761ALATECH POWDER FREE LATEX EXAMINATION GLOVE
Alatech Healthcare, LLC
LYY
Apr 3, 2009K090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
Wear Safe (Malaysia) Sdn. Bhd., MY
LYY
Jan 27, 2009K083337NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
Terang Nusa Sdn Bhd, MY
LYY
Sep 17, 2008K081910NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
Siam Sempermed Corp., Ltd.
LYY
Sep 3, 2008K081907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
Siam Sempermed Corp., Ltd.
LYY
Aug 28, 2008K081488POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Pt. Maja Agung Latexindo
LYY
Aug 28, 2008K081464STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
Cardinalhealth
LYY
Aug 7, 2008K080606ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
Alatech Healthcare, LLC
LYY
May 20, 2008K081040POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
Pt.Shamrock Manufacturing Corp.
LYY
May 16, 2008K072300POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
Perusahaan Pelindung Getah (M) Sdn Bhd
LYY
Apr 15, 2008K072614MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
Matang Mfg. Sdn. Bhd., MY
LYY

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