The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Vinyl Exam Gloves, Powder Free, Yellow.
| Device ID | K003091 |
| 510k Number | K003091 |
| Device Name: | MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW |
| Classification | Vinyl Patient Examination Glove |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-10-24 |