The following data is part of a premarket notification filed by Xuzhou Full Sun Medical Products Ltd. with the FDA for Disposable Vinyl Examination Glove, Powdered.
Device ID | K072472 |
510k Number | K072472 |
Device Name: | DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED |
Classification | Vinyl Patient Examination Glove |
Applicant | XUZHOU FULL SUN MEDICAL PRODUCTS LTD. BIHE INDUSTRY AREA YITANG TOWN, PIZHOU COUNTY Jiangsu, CN |
Contact | Hsun-hui Huang |
Correspondent | Hsun-hui Huang XUZHOU FULL SUN MEDICAL PRODUCTS LTD. BIHE INDUSTRY AREA YITANG TOWN, PIZHOU COUNTY Jiangsu, CN |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-04 |
Decision Date | 2007-10-25 |
Summary: | summary |