(84 days)
No predicate devices mentioned.
Not Found
No
The 510(k) summary describes a standard surgical glove and its testing for chemotherapy drug permeation. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML.
No
The device is a surgeon's glove, which is a barrier device for protection, not one that treats or diagnoses a disease or condition.
No
Explanation: The device, a surgeon's glove, is intended for protective purposes during surgery by preventing contamination and permeation by chemotherapy drugs. It does not gather information for diagnosis.
No
The device is a physical glove made of natural rubber latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and to protect the user from chemotherapy drugs. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces the barrier function of the glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the glove's ability to resist permeation by chemotherapy drugs, which is a measure of its barrier effectiveness, not its diagnostic capability.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgeon's glove does not fit that description.
N/A
Intended Use / Indications for Use
The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
| Bleomycin (15 mg/ml) | >240 minutes |
|---|---|
| Busulfan (6 mg/ml) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes |
| Carmustine (3.0 mg/ml) | 12.0 minutes (13.2, 12.9, 12.0) |
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 minutes |
| Cytarabine 100 mg/ml | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes |
| Mechlorethamine HCI (1.0 mg.ml) | >240 minutes |
| Melphalan (5 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes |
| Paraplatin (10 mg/ml) | >240 minutes |
| Rituximab (10 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 22.4 minutes (22.6, 22.4, 23.1) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Warning: Do not use with Carmustine and Thiotepa
Product codes
KGO, LZC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon's and or operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
November 18, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202449
Trade/Device Name: Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of 240 minutes |
|---------------------------------------|---------------------------------|
| Busulfan (6 mg/ml) | >240 minutes |
| Carboplatin (10.0 mg/ml) | >240 minutes |
| Carmustine (3.0 mg/ml) | 12.0 minutes (13.2, 12.9, 12.0) |
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 minutes |
| Cytarabine 100 mg/ml | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | >240 minutes |
| Fludarabine (25.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Idarubicin (1.0 mg/ml) | >240 minutes |
| Ifosfamide (50.0 mg/ml) | >240 minutes |
| Mechlorethamine HCI (1.0 mg.ml) | >240 minutes |
| Melphalan (5 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes |
| Paraplatin (10 mg/ml) | >240 minutes |
| Rituximab (10 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 22.4 minutes (22.6, 22.4, 23.1) |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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