Laglove M Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Laglove M Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8043785
• FEI Number: 1000153953
• Name: Jerry Doane
• Owner & Operator: LAGLOVE (M) SDN. BHD
• Contact Address: LOT 478, JALAN SIMPANG BALAK, OFF BATU 13, JALAN CHERAS; KAJANG, SELANGOR, DARUL EHSAN MY-NOTA 43000 MY
• Official Correspondent:
  • BASKARAN - GOVINDASAMY
  • 60-3873-35411-x
• US Agent:
  • Jerry Doane
  • Pragmatic Compliance LLC
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15815 SW 11th Court Rd. ; Ocala, FL 34473 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K093193 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	Laglove Brand Latex Examination	2010-07-22
PMN K093193 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	Gloves,Powder free,Non-Sterile	2010-07-22
PMN K093193 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	(Pink,Green,Violet)	2010-07-22
PMN K092499 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	laglove brand latex examination	2010-07-22
PMN K092499 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	gloves,powdered non-sterile,	2010-07-22
PMN K092499 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	(Pink,Green,Violet)	2010-07-22
PMN K093335 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)	2010-06-18
PMN K092499 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)	2009-11-20
PMN K092498 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)	2009-11-20
PMN K991749 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K991748 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K990882 | LZA Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K990420 | LZA Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K990285 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K990268 | LYY Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K042618 | FMC Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K010860 | LZA Jerry Doane [LAGLOVE (M) SDN. BHD]	LAGLOVE BRAND	2007-12-05
PMN K042618 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)	2004-11-26
PMN K010860 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)	2001-04-03
PMN K991950 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)	1999-08-12
PMN K991949 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)	1999-08-12
PMN K990883 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)	1999-08-10
PMN K992019 LAGLOVE (M) SDN. BHD.	LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)	1999-08-05
PMN K992018 LAGLOVE (M) SDN. BHD.	LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)	1999-07-30
PMN K991749 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE	1999-06-23
PMN K991748 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G	1999-06-23
PMN K990882 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)	1999-05-21
PMN K990420 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)	1999-03-29
PMN K990415 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)	1999-03-29
PMN K990268 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)	1999-02-24
PMN K990285 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)	1999-02-18
PMN K990270 LAGLOVE (M) SDN. BHD.	LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)	1999-02-18
PMN K912988 LAGLOVE (M) SDN. BHD.	LATEX EXAMINATION GLOVES	1991-08-02

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009298536	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVES	2251 CTN
2020092940549	Xiamen,China (Mainland) -> Los Angeles, California	RUBBER GLOVE	1100 CTN
2020092832056	Xiamen,China (Mainland) -> Los Angeles, California	RUBBER GLOVE	1100 CTN
202009259825	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVES	2251 CTN
2020091915289	Xiamen,China (Mainland) -> Los Angeles, California	RUBBER GLOVE	1911 CTN
202007063660	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	RUBBER GLOVES	2332 CTN
2020062712076	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	644 CTNS OF NITRILE EXAMINATION GLOVES - 245MM 5 MIL FULLY RAISED DIAMOND PATTERN TEXTURED ONLINE (PACKED IN GET A GRIP BRAND BOXES & CARTONS) 492 CTNS OF NITRILE EXAMINATION GLOVES - 240MM POWDERFREE FINGER TEXTURED DARK BLUE COLOR NON-STERILE 5 MIL (PACKED IN 'MILKERS HELPERS' BRAND BOXES &	1144 CTN
2020062517737	Pusan,South Korea -> Long Beach, California	RUBBER GLOVE	1173 CTN