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 |