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 Gloves (green).
| Device ID | K152692 |
| 510k Number | K152692 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves (Green) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Supermax Plastic Products Co., Ltd 314 Dragon River East Road Shijiazhuang City, CN 050000 |
| Contact | Wu Zhigang |
| Correspondent | Kathy Liu HONGRAY USA MAEDICAL PRODUCTS INC 3973 SCHAEFER AVE. 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 | 2015-09-21 |
| Decision Date | 2015-12-21 |
| Summary: | summary |