COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES

Latex 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 Powder Free Polymer Coated Latex Examination Glove, Non Sterile With Protein Labeling Claim (50 Micrograms Or Les.

Pre-market Notification Details

• Device ID: K001280
• 510k Number: K001280
• Device Name: COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
• Classification: Latex 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: LYY
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-21
• Decision Date: 2000-05-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30850015055059	K001280	000
30850015055042	K001280	000
30850015055035	K001280	000
30850015055028	K001280	000