The following data is part of a premarket notification filed by Interpro Intl., Inc. with the FDA for Surgeons Gloves.
| Device ID | K881374 |
| 510k Number | K881374 |
| Device Name: | SURGEONS GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Contact | Kenneth W Simms |
| Correspondent | Kenneth W Simms INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-08-05 |