The following data is part of a premarket notification filed by Siam Sempermed Corp. Ltd. with the FDA for Non-sterile, Powdered Latex Examination Glove.
Device ID | K081910 |
510k Number | K081910 |
Device Name: | NON-STERILE, POWDERED LATEX EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
Contact | John Calhoun |
Correspondent | John Calhoun SIAM SEMPERMED CORP. LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-03 |
Decision Date | 2008-09-17 |
Summary: | summary |