Submission Details
| 510(k) Number | K252505 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 08, 2025 |
| Decision Date | August 28, 2025 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Powder-Free Vinyl Exam Gloves, clear
Aug 2025
Decision
20d
Days
Class 1
Risk
About This 510(k) Submission
K252505 is an FDA 510(k) clearance for the Powder-Free Vinyl Exam Gloves, clear, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Basic Medical Technology, Inc. (Ontario, US). The FDA issued a Cleared decision on August 28, 2025, 20 days after receiving the submission on August 8, 2025. 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. |
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