The following data is part of a premarket notification filed by Glw Intl. Corp. with the FDA for Patient Examination Gloves.
| Device ID | K892769 |
| 510k Number | K892769 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | GLW INTL. CORP. 2711 BLARNEY WAY Duluth, GA 30136 |
| Contact | Li Z Wen |
| Correspondent | Li Z Wen GLW INTL. CORP. 2711 BLARNEY WAY Duluth, GA 30136 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-10-31 |