The following data is part of a premarket notification filed by Liaoning-usa Corp. with the FDA for Patient Examination Gloves.
Device ID | K892774 |
510k Number | K892774 |
Device Name: | 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 | 1989-09-13 |