The following data is part of a premarket notification filed by Arent Fox with the FDA for Natural Rubber Latex Surgeons Glove.
| Device ID | K944053 |
| 510k Number | K944053 |
| Device Name: | NATURAL RUBBER LATEX SURGEONS GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1995-04-25 |