Submission Details
| 510(k) Number | K192635 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2019 |
| Decision Date | January 17, 2020 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Jan 2020
Decision
116d
Days
Class 1
Risk
About This 510(k) Submission
K192635 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on January 17, 2020, 116 days after receiving the submission on September 23, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LZA — Polymer Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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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