The following data is part of a premarket notification filed by Shijiazhuang Hongray Plastic Products Co., Ltd. with the FDA for Sensi-pro Disposable Powdered Vinyl Synthetic Examination Gloves, Beige Color.
| Device ID | K994206 |
| 510k Number | K994206 |
| Device Name: | SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST ROAD SHIJIAZHUANG CITY Hebei Province, CN 050081 |
| Contact | Gui-xi Liu |
| Correspondent | Gui-xi Liu SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST ROAD SHIJIAZHUANG CITY Hebei Province, CN 050081 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-14 |
| Decision Date | 2000-02-07 |