NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Polymer Patient Examination Glove

SIAM SEMPERMED CORP. LTD.

The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Nitrile Patient Examination Glove Powder-free (blue Color) Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

• Device ID: K021220
• 510k Number: K021220
• Device Name: NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS
• Classification: Polymer Patient Examination Glove
• Applicant: SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684
• Contact: John V Calhoun
• Correspondent: John V Calhoun; SIAM SEMPERMED CORP. LTD. 30798 US HWY 19 NORTH Palm Harbor, FL 34684
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-03-22
• Decision Date: 2002-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30850015055134	K021220	000
30850015055127	K021220	000
30850015055110	K021220	000
30850015055103	K021220	000