The following data is part of a premarket notification filed by Shandong Intco Medical Products Co, Ltd. with the FDA for Latex Examination Gloves, Powder Free.
| Device ID | K213509 |
| 510k Number | K213509 |
| Device Name: | Latex Examination Gloves, Powder Free |
| Classification | Latex Patient Examination Glove |
| Applicant | Shandong Intco Medical Products Co, Ltd. 9888 Qiwang Road, Naoshan Industrial Park Qingzhou, CN 2625000 |
| Contact | Haisheng Yu |
| Correspondent | John Zhao Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, CA 91764 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-02 |
| Decision Date | 2022-04-08 |