Submission Details
| 510(k) Number | K052568 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2005 |
| Decision Date | November 28, 2005 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
ESTEEM STRETCHY VINYL GLOVE WITH COATING
Nov 2005
Decision
70d
Days
Class 1
Risk
About This 510(k) Submission
K052568 is an FDA 510(k) clearance for the ESTEEM STRETCHY VINYL GLOVE WITH COATING, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on November 28, 2005, 70 days after receiving the submission on September 19, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LYZ — Vinyl Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |
Manufacturer
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