The following data is part of a premarket notification filed by Care-pro Industries, Inc. with the FDA for Surgeon's Gloves.
| Device ID | K892495 |
| 510k Number | K892495 |
| Device Name: | SURGEON'S GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | CARE-PRO INDUSTRIES, INC. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
| Contact | Alex Lai |
| Correspondent | Alex Lai CARE-PRO INDUSTRIES, INC. 10605 BOOMER CIRCLE SUITE 101 Dallas, TX 75238 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-10-11 |