The following data is part of a premarket notification filed by Ansell Perry with the FDA for Conform No Powder (protein Labeling Claim) Examination Gloves.
Device ID | K972785 |
510k Number | K972785 |
Device Name: | CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES |
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 | 1997-07-25 |
Decision Date | 1997-09-19 |
Summary: | summary |