The following data is part of a premarket notification filed by Modern Healthcare Corp. with the FDA for Sterile Latex Powder-free Surgical Gloves.
| Device ID | K191898 |
| 510k Number | K191898 |
| Device Name: | Sterile Latex Powder-Free Surgical Gloves |
| Classification | Surgeon's Gloves |
| Applicant | Modern Healthcare Corp. No. 751, Chung Chou Road, Sec. 2, Tien Chung County Chang-hwa, TW 520456 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu City, TW 30067 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-16 |
| Decision Date | 2019-12-18 |