(112 days)
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Not Found
No
The 510(k) summary describes surgical gloves and their performance against chemotherapy drugs. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device, "Powder Free Surgical gloves," is described as a sterile disposable device intended to be worn for protection against contamination, not for treating a disease or condition.
No
Explanation: The device described is powder-free surgical gloves intended to protect a surgical wound from contamination and to be worn by operating room personnel. It is a protective barrier, not a device used to diagnose medical conditions.
No
The device described is a physical product (surgical gloves) and not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used externally on the body for protection.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with or analyze such specimens.
- Testing for Chemotherapy Permeation: While the gloves were tested for their ability to resist permeation by chemotherapy drugs, this testing is related to the protective function of the glove as a barrier, not to diagnosing or monitoring a patient's health condition.
Therefore, the primary function and intended use of these surgical gloves fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 22.0 |
| Thiotepa (10.0mg/ml) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 |
"WARNING: Do not use with Carmustine and Thiotepa"
Product codes
KGO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy. Results are:
- Fluorouracil (50.0mg/ml): >240 minutes
- Etoposide (20.0mg/ml): >240 minutes
- Cyclophosphamide (20.0mg/ml): >240 minutes
- Carmustine (3.3mg/ml): 22.0 minutes
- Thiotepa (10.0mg/ml): 24.2 minutes
- Paclitaxel (6.0mg/ml): >240 minutes
- Doxorubicin Hydrochloride (2.0mg/ml): >240 minutes
- Methotrexate (25.0mg/ml): >240 minutes
- Vincristine Sulfate (1.0mg/ml): >24 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2021
Careplus (M) SDN BHD Lim Shyan CEO/Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K210656
Trade/Device Name: ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 22.0 |
| Thiotepa (10.0mg/ml) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 |
"WARNING: Do not use with Carmustine and Thiotepa"
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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