The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Latex Examination Gloves.
| Device ID | K913409 |
| 510k Number | K913409 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TOP GLOVE SDN. BHD. 24, JALAN RAJA MOKHTAR DUA 42200 KAPAR, SELANGOR D.E. Malaysia, ML |
| Contact | Bee Tong |
| Correspondent | Bee Tong TOP GLOVE SDN. BHD. 24, JALAN RAJA MOKHTAR DUA 42200 KAPAR, SELANGOR D.E. Malaysia, ML |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1991-09-27 |