Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

Surgeon's Gloves

SEMPERIT INVESTMENTS ASIA PTE. LTD.

The following data is part of a premarket notification filed by Semperit Investments Asia Pte. Ltd. with the FDA for Sempermed Syntegra Ir, Sterile Powder Free Synthetic Rubber Surgeons Gloves.

Pre-market Notification Details

Device IDK160781
510k NumberK160781
Device Name:Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
ClassificationSurgeon's Gloves
Applicant SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road #29 - 03 To 06 Jtc Summit Singapore,  SG 609434
ContactClemens Eichler
CorrespondentThomas C. Knott
BENJAMIN L. ENGLAND & ASSOCIATES, LLC 810 LANDMARK DR, SUITE 126 Glen Burnie,  MD  21061
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-22
Decision Date2017-05-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.