The following data is part of a premarket notification filed by Yty Industry (manjung) Sdn. Bhd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892611 |
| 510k Number | K892611 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 30, JALAN LADA HITAM 16/12 40000 SHAH ALAM Selangor, Malaysia, MY |
| Contact | Ching Siew |
| Correspondent | Ching Siew YTY INDUSTRY (MANJUNG) SDN. BHD. LOT 30, JALAN LADA HITAM 16/12 40000 SHAH ALAM Selangor, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-07-14 |