The following data is part of a premarket notification filed by Apex Medical Technologies, Inc. with the FDA for Hi-touch (tm) Brand Surgical Gloves.
| Device ID | K874539 |
| 510k Number | K874539 |
| Device Name: | HI-TOUCH (TM) BRAND SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Contact | Alice A Depaul |
| Correspondent | Alice A Depaul APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 San Diego, CA 92121 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-03 |
| Decision Date | 1987-12-14 |