The following data is part of a premarket notification filed by Betelcare Sdn Bhd with the FDA for Betel Powder Free Latex Exam Gloves.
| Device ID | K000650 |
| 510k Number | K000650 |
| Device Name: | BETEL POWDER FREE LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BETELCARE SDN BHD 71/2 MILES, OFF JALAN KAPAR KAPAR Selangor Darul Ehsan, MY 42200 |
| Contact | K.b. Siah |
| Correspondent | K.b. Siah BETELCARE SDN BHD 71/2 MILES, OFF JALAN KAPAR KAPAR Selangor Darul Ehsan, MY 42200 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-04-20 |