The following data is part of a premarket notification filed by Toptech Industry Corp. with the FDA for Latex Examination Gloves.
Device ID | K893293 |
510k Number | K893293 |
Device Name: | LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | TOPTECH INDUSTRY CORP. 785 CHUNG HWA RD.,CHUNG PU HSIANG Chiayi Hsien, TW 60602 |
Contact | Mark Lin |
Correspondent | Mark Lin TOPTECH INDUSTRY CORP. 785 CHUNG HWA RD.,CHUNG PU HSIANG Chiayi Hsien, TW 60602 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-18 |
Decision Date | 1989-09-13 |