The following data is part of a premarket notification filed by Ever Light Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera (yellow, White, Blue).
| Device ID | K102655 |
| 510k Number | K102655 |
| Device Name: | POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) |
| 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 | 2010-09-15 |
| Decision Date | 2010-10-29 |