The following data is part of a premarket notification filed by Ansell Perry with the FDA for The Original Perry, Style 42 White Latex Powdered Surgical Gloves With Protein Content Labeling Claim (60 Micrograms Or.
Device ID | K993857 |
510k Number | K993857 |
Device Name: | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-15 |
Decision Date | 2000-01-31 |
Summary: | summary |