The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Latex Patient Examination Gloves Powdered With Protein Content Labeling Claim; 100 Microgram Or Less Of Total Water Extr.
| Device ID | K002314 |
| 510k Number | K002314 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR |
| Classification | Latex Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT Selangor, MY 41720 |
| Contact | Tan Kong Chang |
| Correspondent | Tan Kong Chang PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT Selangor, 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 | 2000-07-31 |
| Decision Date | 2000-08-17 |