The following data is part of a premarket notification filed by Liaoning-usa Corp. with the FDA for Antelope Brand Patient Examination Gloves.
| Device ID | K892781 |
| 510k Number | K892781 |
| Device Name: | ANTELOPE BRAND PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
| Contact | Diana Bryan |
| Correspondent | Diana Bryan LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
| 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 | 1989-09-21 |