The following data is part of a premarket notification filed by Isratech Marketing Corp. with the FDA for Sterile Hypoallergenic Surgeons' Gloves.
| Device ID | K896165 |
| 510k Number | K896165 |
| Device Name: | STERILE HYPOALLERGENIC SURGEONS' GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | ISRATECH MARKETING CORP. 200 MADISON AVE. New York, NY 10016 |
| Contact | Efraim Margolin |
| Correspondent | Efraim Margolin ISRATECH MARKETING CORP. 200 MADISON AVE. New York, NY 10016 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-25 |
| Decision Date | 1989-11-22 |