The following data is part of a premarket notification filed by Ever Light Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves.
| Device ID | K142571 |
| 510k Number | K142571 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | EVER LIGHT PLASTIC PRODUCTS CO., LTD. DONGGAO INDUSTRIAL ZONE ZANHUANG Shijiazhuang, Hebei, CN 050000 |
| Contact | Zhang Litao |
| Correspondent | Kathy Liu HONGRAY USA MEDICAL 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 | 2014-09-12 |
| Decision Date | 2014-12-17 |
| Summary: | summary |