CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

Latex Patient Examination Glove

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Chemo Plus Powder Free Blue Latex Examination Gloves (protein Content Labeling).

Pre-market Notification Details

• Device ID: K972615
• 510k Number: K972615
• Device Name: CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
• Classification: Latex Patient Examination Glove
• Applicant: WEMBLEY RUBBER PRODUCTS (M) SDN BHD LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU Salak Tinggi, Sepang Selangor, MY 43900
• Contact: Chow Yue Wah
• Correspondent: Chow Yue Wah; WEMBLEY RUBBER PRODUCTS (M) 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: 1997-07-14
• Decision Date: 1999-01-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884527004482	K972615	000