The following data is part of a premarket notification filed by Quality Latex Corp. Sdn Bhd with the FDA for Patient Examination Gloves.
| Device ID | K893075 |
| 510k Number | K893075 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | QUALITY LATEX CORP. SDN BHD 32 JALAN SUNGEI BESI 57100 KUALA LUMPUR Malaysia, MY |
| Contact | William Cheong |
| Correspondent | William Cheong QUALITY LATEX CORP. SDN BHD 32 JALAN SUNGEI BESI 57100 KUALA LUMPUR 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 | 1989-04-13 |
| Decision Date | 1989-11-07 |