(224 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML.
No
The device is a disposable examination glove intended to prevent contamination, not to treat a disease or condition.
No
Explanation: The device described is a nitrile examination glove, which is used to prevent contamination between patients and examiners, not to diagnose medical conditions.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component.
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. They are used outside of the body.
- Device Description: The description clearly states this is a "powder free nitrile examination glove" worn on the hands and fingers to prevent contamination. This is a barrier device used on the body, not for analyzing specimens from the body.
- Intended Use: The intended use is to prevent contamination between patient and examiner, and for protection against chemotherapy drugs. This is a protective barrier function, not a diagnostic function.
The fact that it's tested for chemotherapy drug permeation is a performance characteristic related to its barrier function, not an indication that it's used for diagnosis.
N/A
Intended Use / Indications for Use
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU). 3.3mg/ml (3,300ppm) | 8.3 |
| Cisplatin. 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan). 20mg/ml (20,000ppm) | >240 |
| Cytarabine 100mg/ml (100,000ppm) | >240 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride. 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil 50.0mg/ml (50,000ppm) | >240 |
| Ifosfamide. 50.0mg/ml (50,000ppm) | >240 |
| Methotrexate 25mg/ml (25,000ppm) | >240 |
| Mitomycin C. 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone 2.0mg/ml (2,000ppm) | >240 |
| Paclitaxel (Taxol). 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa. 10.0mg/ml (10,000ppm) | 38.0 |
| Vincristine Sulfate 1.0mg/ml (1,000ppm) | >240 |
Product codes
LZA, LZC
Device Description
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands and 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
Not Found
Summary of Performance Studies
The non-clinical performance test results for the subject device met the acceptance criteria in the standard or test method for dimension, physical properties, thickness, freedom from holes, powder residues, chemotherapy permeation, and biocompatibility testing. Clinical data is not needed for the intended use of this subject device.
Key Metrics
Thiotepa. 10.0mg/ml: Minimum Breakthrough Detection Time 38.0 Minutes
Carmustine (BCNU). 3.3mg/ml: Minimum Breakthrough Detection Time 8.3 Minutes
For all other listed chemotherapy drugs, the Minimum Breakthrough Detection Time was >240 Minutes.
Biocompatibility: Primary Skin Irritation-ISO 10993 - non-irritant.
Dermal Sensitization-ISO 10993 - non-sensitizer.
In vitro Cytotoxicity- ISO 10993 - the device extract was not cytotoxic.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows 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.
May 2, 2018
Maxter Glove Manufacturing Sdn Bhd Yap Peak Geeh QA & Regulatory Affairs Manager Lot 6070, Jalan Haji Abdul Manah 6th Miles off Jalan Meru 41050 Klang, Selangor Malaysia
Re: K172864
Trade/Device Name: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: March 30. 2018 Received: April 6, 2018
Dear Yap Peak Geeh:
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device 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.
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.
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,
Geeta K.
Pamidimukkala -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172864
R1/2001
Device Name
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU). 3.3mg/ml (3,300ppm) | 8.3 |
| Cisplatin. 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan). 20mg/ml (20,000ppm) | >240 |
| Cytarabine 100mg/ml (100,000ppm) | >240 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride. 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil 50.0mg/ml (50,000ppm) | >240 |
| Ifosfamide. 50.0mg/ml (50,000ppm) | >240 |
| Methotrexate 25mg/ml (25,000ppm) | >240 |
| Mitomycin C. 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone 2.0mg/ml (2,000ppm) | >240 |
| Paclitaxel (Taxol). 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa. 10.0mg/ml (10,000ppm) | 38.0 |
| Vincristine Sulfate 1.0mg/ml (1,000ppm) | >240 |
3
510(K) SUMMARY
Date Prepared: 30th April 2018
1.0 Submitter:
| Name | : | Maxter Glove Manufacturing Sdn Bhd |
|---|---|---|
| Address | : | Lot 6070 Jalan Haji Abdul Manan, |
| 6th Miles off Jalan Meru, | ||
| 41050 Klang, Selangor, Malaysia. | ||
| Phone No. | : | 603-33929888 |
| Fax No. | : | 603-33923328 |
2.0 Name of the device:
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Common Name Patient Examination Gloves : Brand Name Maxter Classification Name: Polymer Patient Examination Glove (21 CFR 880.6250 Product Code LZA)
3.0 Identification Of The Legally Marketed Devices that equivalency is claimed:
| Predicate | |
|---|---|
| Manufacturer | Kossan International Sdn Bhd |
| Device Name | Powder Free Nitrile Patient Examination |
| Glove, Blue Colored, Non-Sterile. Tested | |
| for Use with Chemotherapy Drugs | |
| 510(k) Number | K151750 |
| Regulation Number | 21 CFR 880.6250 |
| Regulatory Name | Patient Examination Glove |
| Regulatory Class | I |
Patient Examination Gloves Specialty (21 CFR 880.6250 Product Code LZC)
4.0 Description of the Device:
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
5.0 Indications for Use statement for the subject device:
4
A Non-Sterile Powder Free Blue Nitrile Examination Glove Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05.
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU). 3.3mg/ml (3,300ppm) | 8.3 |
| Cisplatin. 1.0 mg/ml (1,000ppm) | >240 |
| Cyclophosphamide (Cytoxan). 20mg/ml (20,000ppm) | >240 |
| Cytarabine 100mg/ml (100,000ppm) | >240 |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 |
| Doxorubicin Hydrochloride. 2.0mg/ml (2,000ppm) | >240 |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000ppm) | >240 |
| Methotrexate 25mg/ml (25,000ppm) | >240 |
| Mitomycin C. 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone 2.0mg/ml (2,000ppm) | >240 |
| Paclitaxel (Taxol) 6.0mg/ml (6,000ppm) | >240 |
| Thiotepa 10.0mg/ml (10,000ppm) | 38 |
| Vincristine Sulfate 1.0mg/ml (1,000ppm) | >240 |
Please note that the following drugs have low permeation time of less than 240minutes: Carmustine (BCNU), 3.3mg/ml: 8.3 Minutes Thiotepa. 10.0mg/ml: 38.0 Minutes
6.0 Summary of the Technological Characteristics Comparison:
Below is the summary of the technological characteristics of the Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs compare to ASTM D6319 or equivalent standards. Chemotherapy claim is similar to predicate device, which has a glove thickness of minimum 0.05mm and is shorter than 270mm but in compliance with the ASTM standards.
| Characteristics | Standards | Device Performance | |
|---|---|---|---|
| Predicate | Current | ||
| Manufacturer | Kossan | ||
| International Sdn | |||
| Bhd | Maxter Gloves | ||
| Manufacturing Sdn | |||
| Bhd | |||
| 510 (K) Number | K151750 | K172864 | |
| Dimensions | ASTM D6319-10 | $\geq$ 230mm | $\geq$ 230mm |
| Physical Properties | ASTM D6319-10 | Meet | Meet |
| Thickness- Finger | |||
| -palm | ASTM D6319-10 | ≥ 0.05mm | ≥ 0.05mm |
| Freedom From | |||
| Holes | ASTM D6319-10 | ||
| and ASTM D5151 | Pass | Pass | |
| Powder Free | |||
| Residue | ASTM D6319-10 | ||
| and ASTM D6124 | Meet | Meet | |
| Resistance to | |||
| Permeation by | |||
| Chemotherapy | |||
| Drugs: | ASTM D6978-05 | ||
| Test Chemotherapy | |||
| Drug | Concentration | Minimum Breakthrough Detection Time | |
| (min) | |||
| Carmustine (BCNU) | 3.3mg/ml | 10.1 | 8.3 |
| Cisplatin | 1.0mg/ml | >240 | >240 |
| Cyclophosphamide | |||
| (Cytoxan) | 20mg/ml | >240 | >240 |
| Cytarabine | 100mg/ml | >240 | >240 |
| Dacarbazine (DTIC) | 10.0mg/ml | >240 | >240 |
| Doxorubicin | |||
| Hydrochloride | 2.0mg/ml | >240 | >240 |
| Etoposide (Toposar) | 20.0mg/ml | >240 | >240 |
| Ifosfamide | 50.0 mg/ml | >240 | >240 |
| Methotrexate | 25mg/ml | >240 | >240 |
| Mitomycin C. | 0.5mg/ml | >240 | >240 |
| Mitoxantrone | 2.0mg/ml | >240 | >240 |
| Paclitaxel (Taxol) | 6.0mg/ml | >240 | >240 |
| Thiotepa | 10.0mg/ml | 30.2 | 38.0 |
| Vincristine Sulfate | 1.0mg/ml | >240 | >240 |
| Warning Statement | Warning: Please note | ||
| that the following | |||
| drugs have extremely | |||
| low permeation times: | |||
| Carmustine(BCNU): | |||
| 10.1 minutes and | |||
| Thiotepa: 30.2 | |||
| minutes | Warning : Please | ||
| note that the | |||
| following drugs have | |||
| low permeation time | |||
| of less than 240 | |||
| minutes: Carmustine | |||
| (BCNU): 8.3 | |||
| minutes and | |||
| Thiotepa: 38.0 | |||
| minutes. Do not use | |||
| with Carmustine or | |||
| Thiotepa. | |||
| Biocompatibility | Primary Skin | ||
| Irritation-ISO 10993 | Under the conditions | ||
| of the study, this is a | |||
| non-irritant. | Under the conditions | ||
| of the study, this is a | |||
| non-irritant. | |||
| Dermal | |||
| Sensitization-ISO | |||
| 10993 | Under the conditions | ||
| of the study, this is a | |||
| non-sensitizer. | Under the conditions | ||
| of the study, this is a | |||
| non-sensitizer. | |||
| In vitro Cytotoxicity- | |||
| ISO 10993 | Not available. | Under the conditions | |
| of the study, the | |||
| device extract was | |||
| not cytotoxic. | |||
| Intended Use | - | A patient examination | |
| glove is a disposable | |||
| device intended for | |||
| medical purposes that | |||
| is worn on the | |||
| examiner's hand to | |||
| prevent | |||
| contamination | |||
| between patient and | |||
| examiner. These | |||
| gloves were tested for | |||
| use with | |||
| chemotherapy drugs | |||
| per ASTM D6978-05 | |||
| (Reapproved 2013) | |||
| Standard Practice for | |||
| Assessment of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy Drugs. | Non-Sterile Powder | ||
| Free Blue Nitrile | |||
| Examination Gloves | |||
| Tested for Use with | |||
| Chemotherapy Drugs | |||
| is a disposable | |||
| device intended for | |||
| medical purposes | |||
| that is worn on the | |||
| examiner's hands | |||
| and finger to prevent | |||
| contamination | |||
| between patient and | |||
| examiner. In | |||
| addition, these | |||
| gloves were tested | |||
| for use with | |||
| chemotherapy drugs | |||
| in accordance with | |||
| ASTMD6978-05. | |||
| Material | ASTM D6319-10 | Nitrile | Nitrile |
| Color | - | Blue, and white | Blue |
| Texture | - | Finger Textured | Finger Textured |
| Size | Medical Glove | ||
| Guidance Manual- | |||
| Labeling | Extra Small | Extra Small | |
| Small | Small | ||
| Medium | Medium | ||
| Large | Large | ||
| Extra Large | Extra Large | ||
| Single Use | Medical Glove | ||
| Guidance Manual- | |||
| Labeling | Single use | Single use |
Table 1
5
6
7.0 Summary of Non-Clinical Performance Data
The non-clinical performance test results for the subject device met the acceptance criteria in the standard or test method for dimension, physical properties, thickness,
7
freedom from holes, powder residues, chemotherapy permeation, and biocompatibility testing.
8.0 Summary of Clinical Performance Data
Not applicable- clinical data is not needed for the intended use of this subject device.
9.0 Conclusion
Based on intended use, technological characteristics and non-clinical performance data, the Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is substantially equivalent to the predicate device K151750.