The following data is part of a premarket notification filed by Boston Medical Corp. with the FDA for Boston Brand Hypoallergenic Latex Gloves.
| Device ID | K923385 |
| 510k Number | K923385 |
| Device Name: | BOSTON BRAND HYPOALLERGENIC LATEX GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | BOSTON MEDICAL CORP. 12011 GUILFORD RD. Annapolis Junction, MD 20701 |
| Contact | Timothy F Hand |
| Correspondent | Timothy F Hand BOSTON MEDICAL CORP. 12011 GUILFORD RD. Annapolis Junction, MD 20701 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-07 |
| Decision Date | 1992-10-15 |