The following data is part of a premarket notification filed by Gigantic International Corp. with the FDA for Patient Examination Gloves (vinyl).
| Device ID | K892766 |
| 510k Number | K892766 |
| Device Name: | PATIENT EXAMINATION GLOVES (VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GIGANTIC INTERNATIONAL CORP. 11727 E. WASHINGTON BLVD. Whittier, CA 90606 |
| Contact | Julie Lee |
| Correspondent | Julie Lee GIGANTIC INTERNATIONAL CORP. 11727 E. WASHINGTON BLVD. Whittier, CA 90606 |
| Product Code | LYZ |
| 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 | 1989-07-14 |