The following data is part of a premarket notification filed by Ever Light Plastic Products Co., Ltd. with the FDA for Synthetic Powder Free (pink) Vinyl Patient Examination Glove.
| Device ID | K082029 |
| 510k Number | K082029 |
| Device Name: | SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | EVER LIGHT PLASTIC PRODUCTS CO., LTD. 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu EVER LIGHT PLASTIC PRODUCTS CO., LTD. 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 | 2008-07-17 |
| Decision Date | 2008-09-26 |
| Summary: | summary |