(230 days)
Not Found
Not Found
No
The summary describes a standard surgical glove and does not mention any AI or ML capabilities.
No.
This device is a surgeon's glove intended to protect a surgical wound from contamination, which is a barrier function, not a therapeutic one. Its use with chemotherapy drugs is for protection, not treatment.
No
Explanation: The device is a surgical glove intended for protection, not for diagnosing a condition or disease.
No
The device is a physical surgical glove, not a software application. The description clearly outlines a hardware product made of synthetic rubber.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgeon's glove... intended to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used during a medical procedure.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: The description of the glove and its testing for chemotherapy drug permeation does not involve the examination of specimens from the human body for diagnostic or monitoring purposes. The testing is related to the protective barrier function of the glove itself.
Therefore, this surgeon's glove falls under the category of a medical device used for protection during surgery, not an IVD.
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.
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
Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml): 37.5 minutes ThioTEPA (10.0 mg/ml): 58.3 minutes
Product codes (comma separated list FDA assigned to the subject device)
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
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): 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
March 28, 2019
PT. Medisafe Technologies Punitha Samy Group Regulatory Affairs Manager JI Batang Kuis. Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar Tanjung Morawa, Medan, 20362 Id
Re: K182176
Trade/Device Name: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: February 22, 2019 Received: March 1, 2019
Dear Punitha Samy:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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.
Clarence W. Murray lii III -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) K182176
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 |
Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml): 37.5 minutes 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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