The following data is part of a premarket notification filed by Shen Wei Usa Inc. with the FDA for Biodegradable Thermoplastic Elastomer Examination (tpe) Glove.
| Device ID | K202078 |
| 510k Number | K202078 |
| Device Name: | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 |
| Contact | Cheryl Reep |
| Correspondent | Cheryl Reep Shen Wei USA Inc. 33278 Central Ave Ste 102 Union City, CA 94587 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2021-03-05 |