The following data is part of a premarket notification filed by Sukas Export with the FDA for Latex Examination Glove.
| Device ID | K882533 |
| 510k Number | K882533 |
| Device Name: | LATEX EXAMINATION GLOVE |
| Classification | Patient Examination Glove |
| Applicant | SUKAS EXPORT 2, LORONG 16/6C, SECTION 16 46350 PETALING JAYA Selangor, Malaysia, MY |
| Contact | Ahmad Abdullah |
| Correspondent | Ahmad Abdullah SUKAS EXPORT 2, LORONG 16/6C, SECTION 16 46350 PETALING JAYA Selangor, Malaysia, MY |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1988-07-21 |