The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powder Free Latex Examination Gloves.
| Device ID | K954365 |
| 510k Number | K954365 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT OFF JALAN KAPAR, PO BOX 188 Selangor Darul Ehsan, MY 41720 |
| Contact | Lim Kuang Sia |
| Correspondent | Lim Kuang Sia PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT OFF JALAN KAPAR, PO BOX 188 Selangor Darul Ehsan, MY 41720 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-12-11 |