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.
| Device ID | K160781 |
| 510k Number | K160781 |
| Device Name: | Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves |
| Classification | Surgeon's Gloves |
| Applicant | SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road #29 - 03 To 06 Jtc Summit Singapore, SG 609434 |
| Contact | Clemens Eichler |
| Correspondent | Thomas C. Knott BENJAMIN L. ENGLAND & ASSOCIATES, LLC 810 LANDMARK DR, SUITE 126 Glen Burnie, MD 21061 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-22 |
| Decision Date | 2017-05-02 |
| Summary: | summary |