The following data is part of a premarket notification filed by Top Glove Sdn. Bhd. with the FDA for Powderfree Latex Examination Gloves.
| Device ID | K932521 |
| 510k Number | K932521 |
| Device Name: | POWDERFREE 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 | Wee Chai |
| Correspondent | Wee Chai 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 | 1993-05-25 |
| Decision Date | 1994-12-13 |