(459 days)
Not Found
Not Found
No
The device is a surgical glove and the summary describes testing for chemotherapy drug permeation, with no mention of AI or ML.
No.
A therapeutic device is one that treats or alleviates a disease or condition. These gloves are protective barriers for operating room personnel during surgery and for protection against chemotherapy drugs, not for treatment.
No
Explanation: The device is surgical gloves, intended to protect users from chemotherapy drugs during invasive surgery. It is a protective barrier, not a tool for diagnosing medical conditions.
No
The device is described as surgical gloves, which are a physical, hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The described device is a surgical glove. Its purpose is to protect both the wearer and the patient during surgery by providing a barrier against contamination and, in this specific case, offering resistance to chemotherapy drugs.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the human body. It is a physical barrier worn on the hands.
- Intended Use: The intended use clearly states it's for "invasive surgery procedures" and is worn by "operating room personnel" to "protect a surgical wound from contamination." This is a protective barrier function, not a diagnostic one.
The testing for chemotherapy drug permeation is a performance characteristic of the glove, not an indication that it performs an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
List of tested Chemotherapy Drugs are as follows:
| Chemotherapy Drug Permeation and Concentration | Average Breaktrough Detection Time (in Minutes) |
|---|
- Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | 12.6 min
- Cisplatin 1.0 mg/ml (1,000ppm) | >240 min
- Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min
- Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min
- Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min
- Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min
- Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min
- Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min
- Methotrexate 25 mg/ml (25,000ppm) | >240 min
- Mitomycin C 0.5 mg/ml (500ppm) | >240 min
- Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min
12.Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min - Thio-Tepa 10.0 mg/ml (10,000ppm) | 12.0 min
- Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Product codes
KGO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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)
The gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. Carmustine and Thio-Tepa showed low permeation times of less than 240 minutes (12.6 min for Carmustine and 12.0 min for Thio-Tepa), while all other listed chemotherapy drugs showed breakthrough detection times greater than 240 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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 9, 2021
GX Corporation Sdn Bhd Khon Foo Managing Director Lot 6491 Batu 5 3/4. Sementa Jalan Kapar Klang, Selangor Darul Ehsan 42100 Malaysia
Re: K200915
Trade/Device Name: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: March 20, 2020 Received: April 6, 2020
Dear Khon Foo:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware 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
1
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 and Part 809 ); medical device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ryan Ortega -S
Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K200915
Device Name
Powder Free White Sterilized Polyisoprene Surgical Gloves - Tested for Use with The Chemotherapy Drugs.
Indications for Use (Describe)
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination .
These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
| List of tested Chemotherapy Drugs are as follows: | |
|---|---|
| Chemotherapy Drug Permeation and Concentration | Average Breaktrough Detection Time |
| (in Minutes) | |
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | 12.6 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min |
| 10. Mitomycin C 0.5 mg/ml (500ppm) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min |
| 12.Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 12.0 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min |
Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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