LATEX PATIENT EXAMINATION GLOVES

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

SIAM SEMPERMED CORP. LTD.

The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Latex Patient Examination Gloves.

Pre-market Notification Details

• Device ID: K895642
• 510k Number: K895642
• Device Name: LATEX PATIENT EXAMINATION GLOVES
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: SIAM SEMPERMED CORP. LTD. 8-10 JOOTEE ANUSORN ROAD HATYAI, SONGKHLA Thailand, TH 90110
• Contact: Cherdkiatgumchai
• Correspondent: Cherdkiatgumchai; SIAM SEMPERMED CORP. LTD. 8-10 JOOTEE ANUSORN ROAD HATYAI, SONGKHLA Thailand, TH 90110
• Product Code: OPE
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-09-19
• Decision Date: 1989-12-05