The following data is part of a premarket notification filed by Golden Bonanza Industrial Corp. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892322 |
| 510k Number | K892322 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | GOLDEN BONANZA INDUSTRIAL CORP. NO. 725 SEC. 4, YEN HAI ROAD FU SHING HSIANG Chang Hwa Hsien, Taiwan, TW |
| Contact | Hwan Wu |
| Correspondent | Hwan Wu GOLDEN BONANZA INDUSTRIAL CORP. NO. 725 SEC. 4, YEN HAI ROAD FU SHING HSIANG Chang Hwa Hsien, Taiwan, TW |
| 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 | 1989-04-28 |