The following data is part of a premarket notification filed by Boston Medical Corp. with the FDA for Guards Latex & Safe-contact Examination Gloves.
| Device ID | K890538 |
| 510k Number | K890538 |
| Device Name: | GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BOSTON MEDICAL CORP. 8350 BRISTOL COURT SUITE 101 Jessup, MD 20794 |
| Contact | Timothy F Hand |
| Correspondent | Timothy F Hand BOSTON MEDICAL CORP. 8350 BRISTOL COURT SUITE 101 Jessup, MD 20794 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-03 |
| Decision Date | 1989-03-10 |