Wear Safe Malaysia Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Wear Safe Malaysia 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 Number3006552561
FEI Number3006552561
NameHAI WANG
Owner & OperatorWEAR SAFE (MALAYSIA) SDN BHD
Contact AddressLOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, OFF JALAN MERU, KLANG, SELANGOR, 41050,
KLANG MY-10 Selangor 41050 MY
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4600 East West Highway, Suite 350
Bethesda, MD 20814 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3010602489
FEI Number3010602489
NameWEAR SAFE (MALAYSIA) SDN BHD
Owner & OperatorWEAR SAFE (MALAYSIA) SDN BHD
Contact AddressLOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, OFF JALAN MERU, KLANG, SELANGOR, 41050,
KLANG MY-10 Selangor 41050 MY
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLOT 5068 & 5069, BATU 4 ? JALAN MERU,
KLANG Selangor, 41050 MY
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Wear Safe (Malaysia) Sdn. Bhd.
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested For Use With Chemotherapy Drugs, With Non-Pyrogenic Labeling Claim2017-09-29
WEAR SAFE (MALAYSIA) SDN. BHD.
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE2010-09-03
WEAR SAFE (MALAYSIA) SDN. BHD.
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE2010-01-19
WEAR SAFE (MALAYSIA) SDN. BHD.
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O2009-10-21
WEAR SAFE (MALAYSIA) SDN. BHD.
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE2009-05-15
WEAR SAFE (MALAYSIA) SDN. BHD.
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE2009-04-03
WEAR SAFE MALAYSIA SDN. BHD.
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (502006-11-02
WEAR SAFE MALAYSIA SDN. BHD.
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)2000-01-20
WEAR SAFE MALAYSIA SDN. BHD.
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE1999-12-16
WEAR SAFE MALAYSIA SDN. BHD.
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES1999-12-16
WEAR SAFE MALAYSIA SDN. BHD.
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED1999-11-17
WEAR SAFE MALAYSIA SDN. BHD.
PATIENT EXAMINATION POWDER-FREE GLOVES1998-01-06

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092814277Port Swettenham,Malaysia -> Norfolk, VirginiaGLOVES1210 CTN
202008272570Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
202008199553Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
2020081411542Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
2020081219459Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
2020080634269Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
2020080525572Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyPURCHASE ORDER NO 17247206 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50 MICROGRAMS PER DM2 OF GLOVE OR LESS OF WATER SOLUBLE PROTEIN BRAND CRITERION - 16 CASES PURCHASE ORDER NO 17247208 2 STERILE POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES CONTAINS 50367 CAS
2020072323970Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyGLOVES675 CTN

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