The following data is part of a premarket notification filed by Industrial Clothings, Ltd. with the FDA for Midas Touch Latex Examination Gloves-powder Free.
Device ID | K000142 |
510k Number | K000142 |
Device Name: | MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE |
Classification | Latex Patient Examination Glove |
Applicant | INDUSTRIAL CLOTHINGS, LTD. 481 A, PRINCE OF WALES AVE. Columbo 14, LK 14 |
Contact | Syed Umair Ahmed |
Correspondent | Syed Umair Ahmed INDUSTRIAL CLOTHINGS, LTD. 481 A, PRINCE OF WALES AVE. Columbo 14, LK 14 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-18 |
Decision Date | 2000-09-13 |