The following data is part of a premarket notification filed by Curon Scientific Co., Ltd with the FDA for Synthetic Vinyl Examination Gloves, Powder Free.
| Device ID | K102337 |
| 510k Number | K102337 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CURON SCIENTIFIC CO., LTD NO. 6-2 XING'AN ROAD E EAST LINQU Weifang, CN 262600 |
| Contact | Peter Wang |
| Correspondent | Peter Wang CURON SCIENTIFIC CO., LTD NO. 6-2 XING'AN ROAD E EAST LINQU Weifang, 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 | 2010-08-18 |
| Decision Date | 2010-11-08 |
| Summary: | summary |