The following data is part of a premarket notification filed by Super Safe Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Glove, Yellow.
| Device ID | K070038 |
| 510k Number | K070038 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUPER SAFE PLASTIC PRODUCTS CO., LTD. 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu SUPER SAFE 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 | 2007-01-03 |
| Decision Date | 2007-03-23 |
| Summary: | summary |