The following data is part of a premarket notification filed by N.s. Uni-gloves Sdn. Bhd. with the FDA for Patient Examination Gloves.
| Device ID | K890965 |
| 510k Number | K890965 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | N.S. UNI-GLOVES SDN. BHD. LOT 3 & 4/4510 SENAWANG IND. ESTATE Seremban N S, MY 70450 |
| Contact | Beng Teck |
| Correspondent | Beng Teck N.S. UNI-GLOVES SDN. BHD. LOT 3 & 4/4510 SENAWANG IND. ESTATE Seremban N S, MY 70450 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-04-28 |