(265 days)
Not Found
Not Found
No
The device is a medical glove, and the summary focuses on its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or diagnose a medical condition.
No
Explanation: The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition. Its performance is measured by chemotherapy drug permeation, which is a safety characteristic, not a diagnostic one.
No
The device is a physical glove, not software. The description clearly outlines a hardware product intended for physical use.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "Patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used externally on the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body to analyze these samples.
- Device Description: The description confirms it's a "Surgical Glove," which is a physical barrier.
- Performance Studies: The performance studies focus on the glove's ability to resist permeation by chemotherapy drugs, which is a measure of its barrier function, not its ability to diagnose or analyze biological samples.
The information provided aligns with the description of a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
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 containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Product codes
KGO
Device Description
Powder Free White , Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
White Glove breakthrough detection times: Carmustine (BCNU) 3.3 mg/ml(3,300 ppm) - 79.0 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) - 79.2 min; Vincristine Sulfate 1.0 mg/ml (1,000ppm) - >240 min.
Blue Glove breakthrough detection times: Carmustine (BCNU) 3.3 mg/ml(3,300 ppm) - 48.5 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) - 169.4 min; Vincristine Sulfate 1.0 mg/ml (1,000ppm) - >240 min.
Key results: Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 9, 2019
Smart Glove Corporation Sdn.Bhd. Khon Foo Managing Director Lot 6487, Batu 5 3/4, Sementa, Jalan Kapar Klang, 42100 My
Re: K181047
Trade/Device Name: Powder Free White, Blue Sterilized Nitrile 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: November 29, 2018 Received: December 3, 2018
Dear Khon Foo:
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.html; 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 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) K181047
Device Name
Powder Free White , Blue Sterilized Nitrile 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 containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves.
| Chemotherapy Drugs: | Breakthrough Detection Time in Minutes | |
|---|---|---|
| White Glove | Blue Glove | |
| 1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) | 79.0 min | 48.5 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) | 79.2 min | 169.4 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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