The following data is part of a premarket notification filed by Ansell Perry with the FDA for Encore Microptic Powder Free Latex Surgical Gloves With Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K000295 |
| 510k Number | K000295 |
| Device Name: | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Surgeon's Gloves |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20811220031194 | K000295 | 000 |
| 20811220031187 | K000295 | 000 |
| 20811220031170 | K000295 | 000 |
| 20811220031163 | K000295 | 000 |
| 20811220031156 | K000295 | 000 |
| 20811220031149 | K000295 | 000 |
| 20811220031132 | K000295 | 000 |
| 20811220031125 | K000295 | 000 |