The following data is part of a premarket notification filed by Zibo Blue Sail Plastic & Rubber Products Co., Ltd. with the FDA for Blue Sail (brand) Powdered Vinyl Patient Examination Gloves.
| Device ID | K032783 |
| 510k Number | K032783 |
| Device Name: | BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. RM 707, AVIC BLDG., NO. 2 DONG SAN HUAN NAN ROAD Chaoyang District, Beijing, CN 100022 |
| Contact | Chen Yuhong |
| Correspondent | Chen Yuhong ZIBO BLUE SAIL PLASTIC & RUBBER PRODUCTS CO., LTD. RM 707, AVIC BLDG., NO. 2 DONG SAN HUAN NAN ROAD Chaoyang District, Beijing, CN 100022 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-11-13 |
| Summary: | summary |