Submission Details
| 510(k) Number | K192232 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2019 |
| Decision Date | November 08, 2019 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Nov 2019
Decision
84d
Days
Class 1
Risk
About This 510(k) Submission
K192232 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on November 8, 2019, 84 days after receiving the submission on August 16, 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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