K203705 is an FDA 510(k) clearance for the Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein). This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Careplus (M) Sdn Bhd (Seremban, MY). The FDA issued a Cleared decision on August 20, 2021, 245 days after receiving the submission on December 18, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. 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..
| 510(k) Number | K203705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2020 |
| Decision Date | August 20, 2021 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |