Submission Details
| 510(k) Number | K211601 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2021 |
| Decision Date | August 22, 2022 |
| Days to Decision | 455 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Powder Free Latex Examination Glove, Non-Sterile
Aug 2022
Decision
455d
Days
Class 1
Risk
About This 510(k) Submission
K211601 is an FDA 510(k) clearance for the Powder Free Latex Examination Glove, Non-Sterile, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 22, 2022, 455 days after receiving the submission on May 24, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LYY — Latex Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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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