The following data is part of a premarket notification filed by Glen Nevis Co. with the FDA for Sunnytex Latex Examination Gloves.
| Device ID | K892577 |
| 510k Number | K892577 |
| Device Name: | SUNNYTEX LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | GLEN NEVIS CO. 609 STONEGATE DR. South San Francisco, CA 94080 |
| Contact | Helen Soegandhi |
| Correspondent | Helen Soegandhi GLEN NEVIS CO. 609 STONEGATE DR. South San Francisco, CA 94080 |
| 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 | 1989-05-31 |