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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
Sep 8, 2000K002111RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
Perusahaan Pelindung Getah (M) Sdn Bhd, ML
LYY
Aug 22, 2000K002065PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LYY
Aug 17, 2000K002314LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
Perusahaan Getah Asas Sdn. Bhd., MY
LYY
Aug 14, 2000K002112RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE
Perusahaan Pelindung Getah (M) Sdn Bhd, ML
LYY
Aug 11, 2000K002114RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
Perusahaan Pelindung Getah (M) Sdn Bhd, ML
LYY
Aug 10, 2000K000913POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Handsafe Products Sdn. Bhd., MY
LYY
Jul 31, 2000K002176NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE
Sgmp Co., Ltd.
LYY
Jul 31, 2000K002175NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
Sgmp Co., Ltd.
LYY
Jul 27, 2000K001739POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
Allegiance Healthcare Corp.
LYY
Jul 27, 2000K000050TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
Top Quality Mfg., Inc.
LYY
Jul 5, 2000K001715POWDERED PATIENT EXAMINATION GLOVES, LATEX
Fitco Dipped Products Pvt., Ltd., IN
LYY
Jul 5, 2000K001165POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Medipure Corporation (M) Sdn. Bhd., MY
LYY
Jun 30, 2000K001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
Pamitex Industries Sdn Bhd, MY
LYY
Jun 30, 2000K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
Pamitex Industries Sdn Bhd, MY
LYY
Jun 23, 2000K001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
Pamitex Industries Sdn Bhd, MY
LYY
Jun 23, 2000K000351HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
Hanwella Rubber Products , Ltd., LK
LYY
Jun 13, 2000K001485HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
Pwa Industries Sdn. Bhd., MY
LYY
Jun 13, 2000K001475HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
Pwa Industries Sdn. Bhd., MY
LYY
Jun 12, 2000K001529POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
Perusahaan Getah Asas Sdn. Bhd., MY
LYY
Jun 9, 2000K001557LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
Kossan Latex Industries(M)Sdn Bhd, MY
LYY
Jun 9, 2000K000377MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
Masif Healthcare Products Sdn. Bhd., MY
LYY
May 23, 2000K994426GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
Pt. Wrp Buana Multicorpora, ID
LYY
May 23, 2000K001327POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
Premier Pathway Sdn. Bhd.
LYY
May 23, 2000K001190POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
Kossan Latex Industries(M)Sdn Bhd, MY
LYY
May 23, 2000K001042COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LYY
May 22, 2000K000999MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Multisafe Sdn. Bhd., MY
LYY
May 15, 2000K993760POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
Hartalega Sdn Bhd, MY
LYY
May 15, 2000K001280COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
Wrp Asia Pacific Sdn. Bhd., MY
LYY
May 15, 2000K001232NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
Fitco Dipped Products Pvt., Ltd., IN
LYY
May 9, 2000K001141POWDER FREE STERILE LATEX EXAMINATION GLOVES
Allegiance Healthcare Corp.
LYY
May 3, 2000K000745SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Tillotson Healthcare Corp.
LYY
Apr 28, 2000K001216POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Fitco Dipped Products Pvt., Ltd., IN
LYY
Apr 28, 2000K001094SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
Jb Star Sdn Bhd, MY
LYY
Apr 28, 2000K000891STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
Fitco Dipped Products Pvt., Ltd., IN
LYY
Apr 28, 2000K000668POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
Protection Gloves Sdn. Bhd., MY
LYY
Apr 28, 2000K000667POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
Protection Gloves Sdn. Bhd., MY
LYY
Apr 24, 2000K000985MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
Matang Mfg. Sdn. Bhd.
LYY
Apr 21, 2000K000867POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
Sgmp Co., Ltd., TH
LYY
Apr 20, 2000K000650BETEL POWDER FREE LATEX EXAM GLOVES
Betel Care Sdn. Bhd., MY
LYY
Apr 12, 2000K991677REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
London International Group, Inc.
LYY
Apr 12, 2000K000584POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Shasta Asia Partners Gloves Manufacturing CO , Ltd.
LYY
Apr 12, 2000K000555TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
Tekmedic (M) Sdn Bhd
LYY
Apr 12, 2000K000391VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Sgmp Co., Ltd.
LYY
Apr 12, 2000K000390VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Sgmp Co., Ltd.
LYY
Apr 10, 2000K000652BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Betel Care Sdn. Bhd., MY
LYY
Apr 7, 2000K000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
Pamitex Industries Sdn Bhd, MY
LYY
Apr 5, 2000K000725HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Hwa Teh Industrial Sdn. Bhd., MY
LYY
Mar 29, 2000K000671POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
Sgmp Co., Ltd.
LYY
Mar 20, 2000K000488VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB
Sgmp Co., Ltd.
LYY
Mar 17, 2000K000644SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
Supermax Glove Manufacturing Sdn Bhd, MY
LYY

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