(91 days)
Not Found
Not Found
No
The summary describes a medical glove and its performance against chemotherapy drugs, with no mention of AI or ML.
No
The device is described as an "Examination Glove" intended to prevent contamination, not to treat a medical condition or disease. It is a barrier device for examination purposes.
No
Explanation: The description states the device is an "Examination Glove," which is used for protection and not for diagnosing medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a glove worn on the hand or finger to prevent contamination between the patient and examiner. This is a barrier device for personal protection and infection control.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This glove does not perform any such test.
- Device Description: The description confirms it's a glove.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The testing mentioned (ASTM D 6978-05) is related to the glove's barrier properties against chemotherapy drugs, not diagnostic testing.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05
Product codes
LZA, LZC
Device Description
Powder Free Nitrile Examination Glove -- Blue (Chemotherapy)
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
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
Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05 Permeation Test Results.
Carmustine (BCNU), 3.3 mg/ml (3,300 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000ppm)
Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm)
Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm)
Etoposide (Toposar), 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50.0 mg/ml (50,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin C, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm)
Thiotepa, 10.0 mg/ml (10,000 ppm)
Vincristine Sulfate, 1.0 mg/ml (1,000 ppm)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Permeation Test Results:
- Carmustine (BCNU), 3.3 mg/ml (3,300 ppm): Minimum Breakthrough Detection Time (Specimen 1/2/3)(Minutes) 60.3 (60.3, 60.5, 60.6)
- Cisplatin, 1.0 mg/ml (1,000 ppm): No breakthrough up to 240 min.
- Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000ppm): No breakthrough up to 240 min.
- Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm): No breakthrough up to 240 min.
- Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm): No breakthrough up to 240 min.
- Etoposide (Toposar), 20.0 mg/ml (20,000 ppm): No breakthrough up to 240 min.
- Fluorouracil, 50.0 mg/ml (50,000 ppm): No breakthrough up to 240 min.
- Ifosfamide, 50.0 mg/ml (50,000 ppm): No breakthrough up to 240 min.
- Methotrexate, 25 mg/ml (25,000 ppm): No breakthrough up to 240 min.
- Mitomycin C, 0.5 mg/ml (500 ppm): No breakthrough up to 240 min.
- Mitoxantrone, 2 mg/ml (2,000 ppm): No breakthrough up to 240 min.
- Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm): No breakthrough up to 240 min.
- Thiotepa, 10.0 mg/ml (10,000 ppm): 156.0 (163.8, 156.0, 165.0)
- Vincristine Sulfate, 1.0 mg/ml (1,000 ppm): No breakthrough up to 240 min.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Matang Manufacturing Sdn. Bhd
Ms. Leslie Leong
Operation Manager
Lot 10, Kawasan Perindustrian Serkam
Mukim Serkam, Merlimau
Melaka, Malaysia 77300
OCT 1 7 2012
Re: K122131
Trade/Device Name: Powder Free Nitrile Examination Glove -- Blue (Chemotherapy). Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: October 4, 2012 Received: October 12, 2012
Dear Ms. Leong:
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.
1
Page 2- Ms. Leong
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 (reporting of medical device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Antheon D. anaton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification For Powder Free Nitrile Examination Glove - Blue (Chemotherapy)
| 3.0 | Indication For Use Statement |
|---|---|
| ------------ | ------------------------------------- |
510(K) Number (if known): K122131
Device Name : Powder Free Nitrile Examination Glove - Blue (Chemotherapy)
: A Powder Free Nitrile Examination Glove - Blue Indications For Use (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05
Permeation Test Results
| TEST CHEMOTHERAPY DRUG AND
CONCENTRATION | MINIMUM BREAKTHROUGH
DETECTION TIME (Specimen
1/2/3)(Minutes) |
|----------------------------------------------------|---------------------------------------------------------------------|
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 60.3
(60.3, 60.5, 60.6) |
| Cisplatin, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000ppm) | No breakthrough up to 240 min. |
| Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 min. |
| Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 min. |
| Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 min. |
| Fluorouracil, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. |
| Ifosfamide, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. |
| Methotrexate, 25 mg/ml (25,000 ppm) | No breakthrough up to 240 min. |
| Mitomycin C, 0.5 mg/ml (500 ppm) | No breakthrough up to 240 min. |
| Mitoxantrone, 2 mg/ml (2,000 ppm) | No breakthrough up to 240 min. |
| Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 min. |
| Thiotepa, 10.0 mg/ml (10,000 ppm) | 156.0
(163.8, 156.0, 165.0) |
| Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. |
Caution : Testing showed the following drugs have low average breakthrough detection time:
-
Carmustine - 60.3 min
-
Thiotepa - 156.0 min
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
ter Use √
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
División Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
3
510(k) Number: K 12213