The following data is part of a premarket notification filed by Summit Glove, Inc. with the FDA for Nitritech Or Multiple Private Label Non Sterile Powdered Nitrile Examination Gloves.
| Device ID | K093516 |
| 510k Number | K093516 |
| Device Name: | NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUMMIT GLOVE, INC. 310 SOUTH GRANT ST. Minerva, OH 44657 |
| Contact | James Moore |
| Correspondent | James Moore SUMMIT GLOVE, INC. 310 SOUTH GRANT ST. Minerva, OH 44657 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2010-06-29 |
| Summary: | summary |