The following data is part of a premarket notification filed by Rising Crown Industries Ltd. with the FDA for Patient Examination Gloves (latex).
| Device ID | K892091 |
| 510k Number | K892091 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | RISING CROWN INDUSTRIES LTD. FLAT A7-A9, BLK "A". 10/F. HONG KONG IND CENTRE 489-491 Castle Peak Rd. Kowloon, HK |
| Contact | Ying Choi |
| Correspondent | Ying Choi RISING CROWN INDUSTRIES LTD. FLAT A7-A9, BLK "A". 10/F. HONG KONG IND CENTRE 489-491 Castle Peak Rd. Kowloon, HK |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-12-11 |