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 |