The following data is part of a premarket notification filed by Medmark, Inc. with the FDA for Powder Free, Non-sterile, Latex Examination Gloves.
| Device ID | K914498 |
| 510k Number | K914498 |
| Device Name: | POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MEDMARK, INC. 800 IRONWOOD Olathe, KS 66061 |
| Contact | Marjorie Skinner |
| Correspondent | Marjorie Skinner MEDMARK, INC. 800 IRONWOOD Olathe, KS 66061 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1991-11-27 |