The following data is part of a premarket notification filed by Xuzhou Full Sun Medical Products Ltd. with the FDA for Thermoplastic Elastomer (tpe) Hybrid Examination Glove.
| Device ID | K210463 |
| 510k Number | K210463 |
| Device Name: | Thermoplastic Elastomer (TPE) Hybrid Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou, CN 221316 |
| Contact | Hsun-hui Huang |
| Correspondent | Elizabeth Deng Xuzhou Full Sun Medical Products Ltd. 5748 Eaglewood Place Rancho Cucamonga, CA 91739 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2022-01-23 |