The following data is part of a premarket notification filed by Lowenkamp Intl., Inc. with the FDA for Sanoflex-sterile Latex Surgical Gloves.
| Device ID | K903513 |
| 510k Number | K903513 |
| Device Name: | SANOFLEX-STERILE LATEX SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | LOWENKAMP INTL., INC. P.O. BOX 878 Hazlehurst, MS 39083 |
| Contact | William C Lowenkamp |
| Correspondent | William C Lowenkamp LOWENKAMP INTL., INC. P.O. BOX 878 Hazlehurst, MS 39083 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1990-09-14 |