(50 days)
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No
The document describes a surgical glove and its testing for chemotherapy drug permeation, with no mention of AI or ML technology.
No
This device is a surgical glove, intended to protect from contamination, not to provide therapy.
No
The device is a surgical glove intended for protection, not for diagnosing medical conditions.
No
The device is a physical 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 clearly states the device is "intended to be worn by operating room personnel to protect a surgical wound from contamination." This is a protective barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description reinforces the intended use as a protective barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Testing: The testing mentioned (ASTM D6978-05) is related to the glove's barrier properties against chemotherapy drugs, which is a safety and performance test for the glove itself, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Operating room personnel
Description of the training set, sample size, data source, and annotation protocol
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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)
Tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Key results included minimum breakthrough detection time in minutes for various chemotherapy drugs:
- Carmustine (BCNU) (3.3 mg/ml): 78.4
- Cisplatin (1.0 mg/ml): >240
- Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240
- Cytarabine (100 mg/ml): >240
- Dacarbazine (DTIC) (10.0 mg/ml): >240
- Doxorubicin Hydrochloride (2.0 mg/ml): >240
- Etoposide (20.0 mg/ml): >240
- Fluorouracil (50.0 mg/ml): >240
- Ifosfamide (50.0 mg/ml): >240
- Methotrexate (25.0 mg/ml): >240
- Mitomycin C (0.5 mg/ml): >240
- Mitoxantrone (2.0 mg/ml): >240
- Paclitaxel (Taxol) (6.0 mg/ml): >240
- Thiotepa (10.0 mg/ml): 118.8
- Vincristine Sulfate (1.0 mg/ml): >240
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum 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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
Wear Safe (Malaysia) Sdn. Bhd. Cho Sow Fong Regulatory Affairs Manager Lot 5068 & 5069, Batu 4 ½, Jalan Meru, 41050 Klang, Selangor, Malaysia
Re: K172420
Trade/Device Name: Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC Dated: August 9, 2017 Received: August 10, 2017
Dear Cho Sow Fong:
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Sterile Powder Free Nitrile Surgical Gloved. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Indications for Use (Describe)
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 78.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 118.8 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
K172420
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PSC Poblishing Services (301) 443-6740 EF
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K172420
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