The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Glide-on Vinyl Examination Gloves.
| Device ID | K151754 |
| 510k Number | K151754 |
| Device Name: | Glide-On Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason 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 | 2015-06-29 |
| Decision Date | 2016-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40080196167976 | K151754 | 000 |