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 |