The following data is part of a premarket notification filed by Shijiazhuang Lianhe Shunda Plastic Products Co., L with the FDA for Powdered Free (white) Vinyl Patient Examination Gloves.
| Device ID | K070041 |
| 510k Number | K070041 |
| Device Name: | POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu SHIJIAZHUANG LIANHE SHUNDA PLASTIC PRODUCTS CO., L 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 | 2007-01-03 |
| Decision Date | 2007-03-28 |
| Summary: | summary |