COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL

Polymer Patient Examination Glove

WRP ASIA PACIFIC SDN. BHD.

The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (tested For Use With Chemotherapy Drug) Label.

Pre-market Notification Details

• Device ID: K002064
• 510k Number: K002064
• Device Name: COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
• Classification: Polymer Patient Examination Glove
• Applicant: WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Contact: Yue Wah Chow
• Correspondent: Yue Wah Chow; WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-07
• Decision Date: 2000-11-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521041356	K002064	000
10884521040564	K002064	000