The following data is part of a premarket notification filed by Taroko Ent., Ltd. with the FDA for Sterile & Non-sterile Surgeons Gloves.
| Device ID | K882200 |
| 510k Number | K882200 |
| Device Name: | STERILE & NON-STERILE SURGEONS GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | TAROKO ENT., LTD. 65 EAST INDIA ROW, SUITE #10- H BOSTON, MA 02110 -3308 |
| Contact | KEYIN WORTH |
| Correspondent | KEYIN WORTH TAROKO ENT., LTD. 65 EAST INDIA ROW, SUITE #10- H BOSTON, MA 02110 -3308 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1989-02-03 |