The following data is part of a premarket notification filed by Supermax Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Glove.
| Device ID | K093798 |
| 510k Number | K093798 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUPERMAX PLASTIC PRODUCTS CO., LTD. 3973 SCHAEFER AVENUE Chino, CA 91710 |
| Contact | Jie Liu |
| Correspondent | Jie Liu SUPERMAX PLASTIC PRODUCTS CO., LTD. 3973 SCHAEFER AVENUE Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-02-23 |
| Summary: | summary |