The following data is part of a premarket notification filed by Tan Sin Lian Industries Sdn. Bhd. with the FDA for Qualatex Powdered Latex Examination Gloves.
| Device ID | K992557 |
| 510k Number | K992557 |
| Device Name: | QUALATEX POWDERED LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TAN SIN LIAN INDUSTRIES SDN. BHD. NO. 8, TAMAN MARIN JALAN HAJI ABDULLAH Muar, Johor, MY 84000 |
| Contact | Tan Tiow Gin |
| Correspondent | Tan Tiow Gin TAN SIN LIAN INDUSTRIES SDN. BHD. NO. 8, TAMAN MARIN JALAN HAJI ABDULLAH Muar, Johor, MY 84000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09555697505105 | K992557 | 000 |
| 09555697505099 | K992557 | 000 |
| 09555697505082 | K992557 | 000 |
| 09555697505075 | K992557 | 000 |
| 09555697505068 | K992557 | 000 |