The following data is part of a premarket notification filed by Boston Medical Corp. with the FDA for Sterile Powder Free Nitrile Surgeons Gloves (natural, Blue And Green).
| Device ID | K981947 |
| 510k Number | K981947 |
| Device Name: | STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-03 |
| Decision Date | 1999-03-03 |