The following data is part of a premarket notification filed by Ansell Perry with the FDA for Next Step Powder Free Latex Examination Gloves Contains 50 Mcgm Or Less Of Total Water Extractable Protein Per Gram.
| Device ID | K000165 |
| 510k Number | K000165 |
| Device Name: | NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-19 |
| Decision Date | 2000-03-10 |