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 Inf
| Device Type ID | 2663 |
| Device Name | Latex Patient Examination Glove |
| Regulation Description | Non-powdered Patient Examination Glove. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LYY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
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| Device Type ID | 2663 |
| Device | Latex Patient Examination Glove |
| Product Code | LYY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Patient Examination Glove. |
| CFR Regulation Number | 880.6250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANHUI ANYU LATEX PRODUCTS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREPLUS (M) SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARTALEGA NGC SDN. BHD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARTALEGA SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERCATOR MEDICAL (THAILAND) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROFESSIONAL LATEX SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUBE MEDICAL PRODUCT SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANREA HEALTHCARE PRODUCTS PVT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERANG NUSA SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UG GLOBAL RESOURCES SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Device Ingredient Or Reagent Problem | 1 |
| Total Device Problems | 6 |