The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powdered Nitrile Examination Glove, White (non-colored).
| Device ID | K991511 |
| 510k Number | K991511 |
| Device Name: | POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD 42100 KLANG, P.O. BOX 188, 41720 KLANG Selangor, Darul Ehsan, MY 42100 |
| Contact | Tan Kong Chang |
| Correspondent | Tan Kong Chang PERUSAHAAN GETAH ASAS SDN BHD 42100 KLANG, P.O. BOX 188, 41720 KLANG Selangor, Darul Ehsan, MY 42100 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-30 |
| Decision Date | 1999-06-03 |