The following data is part of a premarket notification filed by Reliance Industrial Co., Ltd. with the FDA for Freepinho Vinyl Exam Gloves.
| Device ID | K891506 |
| 510k Number | K891506 |
| Device Name: | FREEPINHO VINYL EXAM GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | RELIANCE INDUSTRIAL CO., LTD. ROOM 5-2, NO. 155, SECTION 1 KEEUNG ROAD Taipei, TW |
| Contact | Charles Chou |
| Correspondent | Charles Chou RELIANCE INDUSTRIAL CO., LTD. ROOM 5-2, NO. 155, SECTION 1 KEEUNG ROAD Taipei, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-04-26 |