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 |