(192 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and does not mention any AI or ML components or functionalities.
No
The device is a surgeon's glove intended for protection against contamination and chemicals, not for treating or preventing disease.
No
The device is a surgeon's glove, intended to protect surgical wounds from contamination and for use with chemotherapy drugs, not for diagnosing medical conditions.
No
The device is a physical surgeon's glove made of synthetic rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a surgeon's glove worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used during a medical procedure, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms it's a glove made of synthetic rubber.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a biological sample
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs, which is relevant to its protective function, not its diagnostic capability.
The fact that it's tested for use with chemotherapy drugs relates to its protective function in a clinical setting, not its use as a diagnostic tool.
N/A
Intended Use / Indications for Use
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
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Mentions image processing
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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
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.)
| Test Chemotherapy Drug and Concentration | Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 20, 2018
Pt. Medisafe Technologies Deepak Bang Commercial Director J1 Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar, Kecamatan Tanjung Morawa Medan, Indonesia 20362
Re: K173258
Trade/Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: March 20, 2018 Received: March 23, 2018
Dear Deepak Bang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173258
Device Name
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use With Chemotherapy Drugs
Indications for Use (Describe)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
| Test Chemotherapy Drug and Concentration | Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes
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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