POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG

Patient Examination Glove, Specialty

PERUSAHAAN GETAH ASAS SDN BHD

The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Glove, Blue Colored Non-sterile (low Deramatitis Potential And Chemotherapy Drug.

Pre-market Notification Details

• Device ID: K102790
• 510k Number: K102790
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
• Classification: Patient Examination Glove, Specialty
• Applicant: PERUSAHAAN GETAH ASAS SDN BHD LOT 1365, BATU 17 JALAN SEMBILANG Klang, Selangor, MY 45800
• Contact: S F Cho
• Correspondent: S F Cho; PERUSAHAAN GETAH ASAS SDN BHD LOT 1365, BATU 17 JALAN SEMBILANG Klang, Selangor, MY 45800
• Product Code: LZC
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-27
• Decision Date: 2010-11-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850064227192	K102790	000
00850064227031	K102790	000
00850064227055	K102790	000
00850064227079	K102790	000
00850064227093	K102790	000
00850064227116	K102790	000
00850064227130	K102790	000
00850064227154	K102790	000
10850064227168	K102790	000
00850064227000	K102790	000