The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powdered Latex Patient Examination Glove With Protein Content Labeling Claim (200 Microgramsper Or Less).
| Device ID | K003737 |
| 510k Number | K003737 |
| Device Name: | POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS) |
| 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 | 2000-12-04 |
| Decision Date | 2001-02-01 |