The following data is part of a premarket notification filed by Betelcare Sdn Bhd with the FDA for Blue Latex Exam Gloves Non Sterile Chlorinated Powder Free.
| Device ID | K073299 |
| 510k Number | K073299 |
| Device Name: | BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | BETELCARE SDN BHD LOT 3342, JALAN KERETAPI LAMA 7 1/2 MI OFF JALAN KAPAR Selangor, Darul Ehsan, MY 42200 |
| Contact | Keng Beng Siah |
| Correspondent | Keng Beng Siah BETELCARE SDN BHD LOT 3342, JALAN KERETAPI LAMA 7 1/2 MI OFF JALAN 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 | 2007-11-23 |
| Decision Date | 2008-03-05 |
| Summary: | summary |