The following data is part of a premarket notification filed by Bber Sound Rubber Industrial Co., Ltd. with the FDA for Patient Examination Glove (latex).
| Device ID | K891868 |
| 510k Number | K891868 |
| Device Name: | PATIENT EXAMINATION GLOVE (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | BBER SOUND RUBBER INDUSTRIAL CO., LTD. PRIME MERIT INT'L CORP. 1214D SANTA ANITA AVE. S. El Monte, CA 91733 |
| Contact | Eric Lo |
| Correspondent | Eric Lo BBER SOUND RUBBER INDUSTRIAL CO., LTD. PRIME MERIT INT'L CORP. 1214D SANTA ANITA AVE. S. El Monte, CA 91733 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-04-12 |