The following data is part of a premarket notification filed by B Und J Instruments with the FDA for Latex Exam Gloves, Non-sterile.
| Device ID | K882583 |
| 510k Number | K882583 |
| Device Name: | LATEX EXAM GLOVES, NON-STERILE |
| Classification | Patient Examination Glove |
| Applicant | B UND J INSTRUMENTS P.O. BOX 3945 City Of Industry, CA 91744 |
| Contact | Aden Ting |
| Correspondent | Aden Ting B UND J INSTRUMENTS P.O. BOX 3945 City Of Industry, CA 91744 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-07-14 |