The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Prepowdered Vinyl Exam Gloves.
| Device ID | K893334 |
| 510k Number | K893334 |
| Device Name: | PREPOWDERED VINYL EXAM GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Contact | Marvin D Schattner |
| Correspondent | Marvin D Schattner DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster, NY 10509 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-08-15 |