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 With Protein Labeling Claim.
| Device ID | K980916 |
| 510k Number | K980916 |
| Device Name: | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM |
| Classification | Latex Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT OFF JALAN KAPAR, KLANG Selangor, Darul Ehsan, MY 42100 |
| Contact | Bob Chan |
| Correspondent | Bob Chan PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT OFF JALAN KAPAR, KLANG Selangor, Darul Ehsan, MY 42100 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-08-18 |