The following data is part of a premarket notification filed by Glovco Malaysia Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K892009 |
| 510k Number | K892009 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | GLOVCO MALAYSIA SDN BHD C/O CARL PARKER ASSOCIATES INC 175N COMMERCE DR, PO BOX 12084 Hauppauge, NY 11788 |
| Contact | Carl Parker |
| Correspondent | Carl Parker GLOVCO MALAYSIA SDN BHD C/O CARL PARKER ASSOCIATES INC 175N COMMERCE DR, PO BOX 12084 Hauppauge, NY 11788 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-30 |
| Decision Date | 1989-04-28 |