(195 days)
Not Found
Not Found
No
The summary describes a surgical glove and its performance against chemotherapy drugs, with no mention of AI or ML.
No
The device is a patient examination glove, which is intended to prevent contamination for both the patient and examiner, not to treat a disease or condition.
No
Explanation: The device is a surgical glove, intended to prevent contamination during examinations. It does not provide any diagnosis or information about a patient's health condition.
No
The device is a physical glove, not software. The description clearly states it is a "Patient examination glove" and "Surgical Gloves".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between the examiner and the patient during medical examinations. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a glove, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs (breakthrough time), which is relevant to its protective function, not a diagnostic function.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This glove does not fit that description.
N/A
Intended Use / Indications for Use
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
Product codes
KGO
Device Description
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
Chemotherapy Drug permeation ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
Carmustine (BCNU)3.3 mg/ml(3,300 ppm)
Cisplatin 1.0 mg/ml (1,000ppm)
Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm)
Dacarbazine (DTIC)10.0 mg/ml(10,000ppm)
Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm)
Etoposide (Toposar) 20.0 mg/ml (20,000ppm)
Fluorouracil 50.0 mg/ml (50,000ppm)
Ifosfamide 50.0 mg/ml (50,000ppm)
Methotrexate 25 mg/ml (25,000ppm)
Mitomycin C 0.5 mg/ml (500ppm)
Mitoxantrone 2.0 mg/ml (2,000ppm)
Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm)
Thio-Tepa 10.0 mg/ml (10,000ppm)
Vincristine Sulfate 1.0 mg/ml (1,000ppm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.)
Breakthrough Detection Time in Minutes for White Glove and Green Glove when exposed to 14 different Chemotherapy Drugs.
White Glove:
Carmustine (BCNU)3.3 mg/ml(3,300 ppm): 108.3 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
Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm): >240 min
Thio-Tepa 10.0 mg/ml (10,000ppm): 118.7 min
Vincristine Sulfate 1.0 mg/ml (1,000ppm): >240 min
Green Glove:
Carmustine (BCNU)3.3 mg/ml(3,300 ppm): 88.2 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
Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm): >240 min
Thio-Tepa 10.0 mg/ml (10,000ppm): 99.4 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.
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.
Smart Glove Corporation Sdn.Bhd Foo Pu Managing Director Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar, Klang, 42100 My
Re: K180221
Trade/Device Name: Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: July 04, 2018 Received: July 16, 2018
Dear Foo Pu:
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. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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) K180221
Device Name
Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
Indications for Use (Describe)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
| Chemotherapy Drugs: | Breakthrough Detection Time in Minutes | |
|---|---|---|
| White Glove | Green Glove | |
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | 108.3 min | 88.2 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | >240 min | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | >240 min | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | >240 min | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | >240 min | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | >240 min | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | >240 min | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | >240 min | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | >240 min | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | 118.7 min | 99.4 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | >240 min | >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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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