(98 days)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
This document describes the Surgical Gloves produced by Hartalega Sdn. Bhd. and their testing against chemotherapy drugs. The information provided exclusively focuses on the performance of the gloves when exposed to various chemotherapy drugs, specifically their "breakthrough times," which is the time it takes for a chemotherapy drug to penetrate the glove material.
I. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each glove type would implicitly be a resistance (breakthrough time) to specific chemotherapy agents. There is no explicit "acceptance criteria" stated as a minimum breakthrough time for all drugs in the general sense; rather, the measured breakthrough times are reported for each drug. The "acceptance" is that the gloves have been tested for use with these drugs and the breakthrough times are provided for the user to determine suitability.
Here's a combined table of the reported device performance for each glove type:
Table 1: Acceptance Criteria (Breakthrough Time) for Nitrile Powder Free Examination Gloves Tested with Chemotherapy Drugs
| Chemotherapy Drug (Concentration) | White Gloves Reported Performance (Breakthrough Time) | Dark Violet Blue Gloves Reported Performance (Breakthrough Time) | Dark Blue Gloves Reported Performance (Breakthrough Time) |
|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes | 15.1 minutes | 1.7 minutes |
| Cisplatin (1.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 15.4 minutes | 46.4 minutes | 10.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes | > 240 minutes | > 240 minutes |
Note: The manufacturer highlights specific drugs with "extremely low permeation times":
- White Gloves: Carmustine (15.1 min), Thiotepa (15.4 min)
- Dark Violet Blue Gloves: Carmustine (15.1 min), Thiotepa (46.4 min)
- Dark Blue Gloves: Carmustine (1.7 min), Thiotepa (10.8 min)
II. Sample Sized used for the test set and the data provenance
The document does not specify the sample size used for the test set (number of gloves or repetitions of each test).
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. However, the manufacturer is Hartalega Sdn. Bhd. which is a Malaysian company. The testing procedures would typically follow recognized international standards for protective equipment, though the specific standard is not listed here.
III. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device testing. The "ground truth" for glove performance against chemotherapy drugs is established through laboratory testing according to standardized protocols (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). It does not involve human expert consensus or clinical evaluation in the same way an AI diagnostic device would.
IV. Adjudication method for the test set
This section is not applicable. As stated above, the "ground truth" is determined by objective laboratory measurements of chemical permeation, not by human interpretation or adjudication.
V. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This document describes physical product performance testing (gloves resisting chemical permeation), not an AI diagnostic or assistance system. Therefore, no MRMC study, human readers, or AI assistance is involved.
VI. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document describes physical product performance testing, not an algorithm or AI system.
VII. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective laboratory measurements of breakthrough time, which quantifies the time it takes for specific chemotherapy drugs to permeate the glove material. This is a direct physical measurement.
VIII. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/ML or modeling application. The product performance is determined by physical testing.
IX. How the ground truth for the training set was established
This section is not applicable for the same reason as VIII. No training set or ground truth for a training set is established for physical performance testing of medical gloves.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Hartalega Sdb. Bhd. Nurual Kong Quality Assurance Senior Manager No.7, Kawasan Perusahaan Suria Bestari Jaya, 45600 MY
Re: K162924
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated December 14, 2016 Received: December 19, 2016
Dear Nurual Kong:
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
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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 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 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, Ph.D. Acting Division 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
:
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotheray Drugs (tered with breakthrough times) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 15.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low permeation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 15.4 minutes with Thiotepa (10.0 mg/ml).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed annound the and review the collection of information. Send comments regarding this burden estimate or any other onpect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
De not Nemo
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Violet Blue (DVBU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 15.1 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 46.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low perneation times of 15.1 minutes with Carmustine (3.3 mg/ml) and 46.4 minutes with Thiotepa (10.0 mg/ml).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU)
Indications for Use (Describe)
The Nitile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Dark Blue (DKBU) is a non sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.
The list of Chemotherapy Drugs tested (with breakthrough times) is as per below:
| Carmustine (BCNU) (3.3 mg/ml) | 1.7 minutes |
|---|---|
| Cisplatin (1.0 mg/ml) | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| Fluorouracil (50.0 mg/ml) | > 240 minutes |
| Methotrexate (25 mg/ml) | > 240 minutes |
| Mitomycin C (0.5 mg/ml) | > 240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| Thiotepa (10.0 mg/ml) | 10.8 minutes |
| Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
- Please note that the following drugs have extremely low permeation times of 1.7 minutes with Carmustine (3.3 mg/ml) and 10.8 minutes with Thiotepa (10.0 mg/ml).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
§ 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.