The following data is part of a premarket notification filed by Shandong Blue Sail Innovation Co., Ltd. with the FDA for Stretch Vinyl Examination Glove Powder Free.
| Device ID | K102160 |
| 510k Number | K102160 |
| Device Name: | STRETCH VINYL EXAMINATION GLOVE POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG BLUE SAIL INNOVATION CO., LTD. EAST SIDE OF XING'AN ROAD, DONGCHENG STREET OFFIE, LINQU Weifang, Shandong, CN 262600 |
| Contact | Yongchen Zhang |
| Correspondent | Yongchen Zhang SHANDONG BLUE SAIL INNOVATION CO., LTD. EAST SIDE OF XING'AN ROAD, DONGCHENG STREET OFFIE, LINQU Weifang, Shandong, CN 262600 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-10-04 |