The following data is part of a premarket notification filed by Inter-continental Industries Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K891630 |
| 510k Number | K891630 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | INTER-CONTINENTAL INDUSTRIES SDN BHD 23A WISMA RANK JALAN BARAT OFF JALAN IMBI, P.O. BOX 11846 50760 Kuala Lumpur, MY |
| Contact | Pun, Ong |
| Correspondent | Pun, Ong INTER-CONTINENTAL INDUSTRIES SDN BHD 23A WISMA RANK JALAN BARAT OFF JALAN IMBI, P.O. BOX 11846 50760 Kuala Lumpur, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-05-11 |