The following data is part of a premarket notification filed by Qilu (china) Good Luck Chemical Fibers, Inc. with the FDA for Latex Examination Gloves.
Device ID | K901136 |
510k Number | K901136 |
Device Name: | LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | QILU (CHINA) GOOD LUCK CHEMICAL FIBERS, INC. MEDICAL DEVICE INSPECTION CO. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Contact | Alan P Schwartz |
Correspondent | Alan P Schwartz QILU (CHINA) GOOD LUCK CHEMICAL FIBERS, INC. MEDICAL DEVICE INSPECTION CO. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-12 |
Decision Date | 1990-04-09 |