The following data is part of a premarket notification filed by Johnson & Johnson Medical, Div. Of Ethicon, Inc. with the FDA for Neutralon Pf Powder Free Brown Latex Surgical Gloves.
| Device ID | K983240 |
| 510k Number | K983240 |
| Device Name: | NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Contact | Margaret Marsh |
| Correspondent | Margaret Marsh JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington, TX 76014 -3631 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-15 |
| Decision Date | 1998-11-30 |
| Summary: | summary |