The following data is part of a premarket notification filed by Asia Pacific Latex Sdn Bhd with the FDA for Latex Patient Examination Gloves.
| Device ID | K924357 |
| 510k Number | K924357 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ASIA PACIFIC LATEX SDN BHD NO. 14, JALAN TAIPING, 33000 KUALA KANGSAR, PERAK DARUL RIDZUAN, MALAYSIA, ML |
| Contact | HONG LEE |
| Correspondent | HONG LEE ASIA PACIFIC LATEX SDN BHD NO. 14, JALAN TAIPING, 33000 KUALA KANGSAR, PERAK DARUL RIDZUAN, 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 | 1992-08-25 |
| Decision Date | 1994-02-03 |