The following data is part of a premarket notification filed by Ansell Perry with the FDA for Nitra-touch Sterile Powder-free Nitrile Medical Examination Glove.
| Device ID | K992768 |
| 510k Number | K992768 |
| Device Name: | NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Contact | James R Chatterton |
| Correspondent | James R Chatterton ANSELL PERRY 1875 HARSH AVE. S.E. Massillon, OH 44646 -7199 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-17 |
| Decision Date | 1999-10-13 |
| Summary: | summary |