The following data is part of a premarket notification filed by Tan Sin Lian Industries Sdn. Bhd. with the FDA for Powder Free Latex Exam Gloves.
| Device ID | K031335 |
| 510k Number | K031335 |
| Device Name: | POWDER FREE LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TAN SIN LIAN INDUSTRIES SDN. BHD. 1133, NORTH 4TH ST. Philadephia, PA 19123 |
| Contact | Lee Tan |
| Correspondent | Lee Tan TAN SIN LIAN INDUSTRIES SDN. BHD. 1133, NORTH 4TH ST. Philadephia, PA 19123 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09555697505150 | K031335 | 000 |
| 09555697505143 | K031335 | 000 |
| 09555697505136 | K031335 | 000 |
| 09555697505129 | K031335 | 000 |
| 09555697505112 | K031335 | 000 |