(160 days)
A powder-free 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.
In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below.
| No. | Chemotherapy Drugs and Concentrations | Breakthrough |
|---|---|---|
| 1. | Blenoxane (15 mg/ml) | > 240 minutes |
| 2. | Busulfan (6 mg/ml) | > 240 minutes |
| 3. | Carboplatin (10 mg/ml) | > 240 minutes |
| 4. | Carmustine (BCNU) (3.3 mg/ml)* | 30.4 minutes |
| 5. | Cisplatin (1.0 mg/ml) | > 240 minutes |
| 6. | Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| 7. | Cytarabine (100 mg/ml) | > 240 minutes |
| 8. | Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| 9. | Daunorubicin (5 mg/ml) | > 240 minutes |
| 10. | Docetaxel (10.0 mg/ml) | > 240 minutes |
| 11. | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| 12. | Ellence (2 mg/ml) | > 240 minutes |
| 13. | Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| 14. | Fludarabine (25 mg/ml) | > 240 minutes |
| 15. | Fluorouracil (50.0 mg/ml) | > 240 minutes |
| 16. | Ganciclovir (10 mg/ml) | > 240 minutes |
| 17. | Gemcitabine (Gemzar) (38 mg/ml) | > 240 minutes |
| 18. | Idarubicin (1 mg/ml) | > 240 minutes |
| 19. | Ifosfamide (50.0 mg/ml) | > 240 minutes |
| 20. | Irinotecan (20.0 mg/ml) | > 240 minutes |
| 21. | Mechlorethamine HCl (1.0 mg/ml) | > 240 minutes |
| 22. | Melphalan (5 mg/ml) | > 240 minutes |
| 23. | Methotrexate (25 mg/ml) | > 240 minutes |
| 24. | Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 25. | Mitomycin C (0.5 mg/ml) | > 240 minutes |
| 26. | Oxaliplatin (5 mg/ml) | > 240 minutes |
| 27. | Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| 28. | Rituximab (10 mg/ml) | > 240 minutes |
| 29. | Thiotepa (10.0 mg/ml) | > 240 minutes |
| 30. | Trisenox (0.1 mg/ml) | > 240 minutes |
| 31. | Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
| 32. | Vinorelbine (10 mg/ml) | > 240 minutes |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are non-sterile, lavender blue colored, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Chemotherapy drugs listed in the Intended Use(s) section below, as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
This document describes the "HG PRO XP® Nitrile Powder Free Examination Gloves Tested For Use with Chemotherapy Drugs" and its substantial equivalence to a predicate device (K113423). The study primarily focuses on non-clinical performance data, specifically addressing the glove's resistance to permeation by chemotherapy drugs and other physical and biological properties.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document provides a comprehensive side-by-side comparison in "Table 1. Side-by-Side Comparison of Predicate Device with Subject Device: Indications for Use, Non-clinical Performance Data and Technological Characteristics" (pages 7-8).
| Characteristics | Acceptance Criteria/Standards | Subject Device Performance |
|---|---|---|
| Primary Indication for Use | Medical Gloves Guidance Manual | A powder-free patient Examination Gloves 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. |
| Additional Indication (Chemo Drugs) | ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | Breakthrough Detection Time (min) for various chemotherapy drugs: - Blenoxane (15 mg/ml): > 240 min - Busulfan (6 mg/ml): > 240 min - Carboplatin (10 mg/ml): > 240 min - Carmustine (BCNU) (3.3 mg/ml): 30.4 min - Cisplatin (1.0 mg/ml): > 240 min - Cyclophosphamide (Cytoxan) (20 mg/ml): > 240 min - Cytarabine (100 mg/ml): > 240 min - Dacarbazine (DTIC) (10.0 mg/ml): > 240 min - Daunorubicin (5 mg/ml): > 240 min - Docetaxel (10.0 mg/ml): > 240 min - Doxorubicin Hydrochloride (2.0 mg/ml): > 240 min - Ellence (2 mg/ml): > 240 min - Etoposide (Toposar) (20.0 mg/ml): > 240 min - Fludarabine (25 mg/ml): > 240 min - Fluorouracil (50.0 mg/ml): > 240 min - Ganciclovir (10 mg/ml): > 240 min - Gemcitabine (Gemzar) (38 mg/ml): > 240 min - Idarubicin (1 mg/ml): > 240 min - Ifosfamide (50.0 mg/ml): > 240 min - Irinotecan (20.0 mg/ml): > 240 min - Mechlorethamine HCl (1.0 mg/ml): > 240 min - Melphalan (5 mg/ml): > 240 min - Methotrexate (25 mg/ml): > 240 min - Mitoxantrone (2.0 mg/ml): > 240 min - Mitomycin C (0.5 mg/ml): > 240 min - Oxaliplatin (5 mg/ml): > 240 min - Paclitaxel (Taxol) (6.0 mg/ml): > 240 min - Rituximab (10 mg/ml): > 240 min - Thiotepa (10.0 mg/ml): > 240 min - Trisenox (0.1 mg/ml): > 240 min - Vincristine Sulfate (1.0 mg/ml): > 240 min - Vinorelbine (10 mg/ml): > 240 min *Noted extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes. |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber |
| Color | - | Lavender Blue |
| Texture | - | Textured Fingers |
| Size | Medical Glove Guidance Manual-Labeling- Issued on January 22, 2008 | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Gloves Guidance Manual -Issued on January 22, 2008 | Single use |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 (Length: 270 mm minimum, Palm Widths for various sizes provided) |
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 (Finger: 0.10 mm minimum, Palm: 0.10 mm minimum) |
| Physical Properties | ASTM D6319-10 | Meet ASTM D6319-10 (Tensile Strength: 14 MPa min (before & after aging), Ultimate Elongation: 500% min (before aging), 400% min (after aging)) |
| Watertight test | ASTM D5151-06 | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet (< 2.0 mg/glove) |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10: 2010 | Pass (Not a primary skin irritant under the conditions of the study) |
| Biocompatibility | Dermal Sensitization - ISO 10993-10: 2010 | Pass (Not a contact sensitizer under the conditions of the study) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the sample size (e.g., number of gloves) used for each specific test (e.g., watertight, chemotherapy permeation). It refers to compliance with standards like ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, and ASTM D6978-05, which would typically specify the required sample sizes for testing. For example, for the watertight test, it states "Pass AQL 1.5," which implies statistical sampling and testing according to the ASTM D5151-06 standard.
- Data Provenance: The manufacturer is "Healthy Glove Co., Ltd" from Hatyai, Songkhla, Thailand (page 4). The data itself is "non-clinical performance data" (page 10) generated to show substantial equivalence to a predicate device. It is prospective testing conducted by the manufacturer or contracted labs to meet regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This type of information is not applicable to this submission. The device is a patient examination glove, and the "ground truth" is established by adherence to recognized international and national standards (ASTM, ISO) for material properties, physical performance, biocompatibility, and chemical resistance. These standards define objective test methods and acceptance criteria, rather than relying on expert human interpretation of complex medical imagery or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., medical imaging reads) where discrepancies need to be resolved. For objective physical and chemical testing of medical gloves, the results are quantitative or pass/fail based on the defined test methodologies of the respective ASTM and ISO standards.
5. 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:
No. This device is a medical glove, not an AI-powered diagnostic or interpretive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study or assessment of human reader improvement with AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical product (medical glove), not an algorithm or software. Standalone performance for an algorithm is not relevant here. The "standalone" performance here refers to the glove's inherent properties and performance tested against predefined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device is based on accepted industry standards and test methods. Specifically:
- Physical properties (dimensions, thickness, tensile strength, elongation) are compared against ASTM D6319-10.
- Watertight integrity is assessed per ASTM D5151-06.
- Residual powder is measured per ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is tested according to ISO 10993-10:2010.
- Resistance to chemotherapy drug permeation is tested according to ASTM D6978-05.
These standards define the methodologies and the acceptable ranges for performance, serving as the objective "ground truth."
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The glove manufacturer produces the gloves, and then specific samples are tested for compliance with standards. There's no iterative learning or model training involved.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant. The "ground truth" for evaluating the glove's performance against its acceptance criteria is established by the test protocols within the cited ASTM and ISO standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2017
Healthy Glove Co., Ltd Teoh Shee Managing Director 119 Kanchanavanich Road, Tambol Patong Hatyai, Songkhla, Thailand 90230
Re: K162381
Trade/Device Name: HG PRO XP® Nitrile Powder Free Examination Gloves Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: November 28, 2016 Received: December 5, 2016
Dear Teoh Shee:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162381
Device Name
HG PRO® XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A powder-free 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.
In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The gloves have been tested with the following drugs and the respective breakthrough detection times are listed belov.
| No. | Chemotherapy Drugs and Concentrations | Breakthrough |
|---|---|---|
| 1. | Blenoxane (15 mg/ml) | > 240 minutes |
| 2. | Busulfan (6 mg/ml) | > 240 minutes |
| 3. | Carboplatin (10 mg/ml) | > 240 minutes |
| 4. | Carmustine (BCNU) (3.3 mg/ml)* | 30.4 minutes |
| 5. | Cisplatin (1.0 mg/ml) | > 240 minutes |
| 6. | Cyclophosphamide (Cytoxan) (20 mg/ml) | > 240 minutes |
| 7. | Cytarabine (100 mg/ml) | > 240 minutes |
| 8. | Dacarbazine (DTIC) (10.0 mg/ml) | > 240 minutes |
| 9. | Daunorubicin (5 mg/ml) | > 240 minutes |
| 10. | Docetaxel (10.0 mg/ml) | > 240 minutes |
| 11. | Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 minutes |
| 12. | Ellence (2 mg/ml) | > 240 minutes |
| 13. | Etoposide (Toposar) (20.0 mg/ml) | > 240 minutes |
| 14. | Fludarabine (25 mg/ml) | > 240 minutes |
| 15. | Fluorouracil (50.0 mg/ml) | > 240 minutes |
| 16. | Ganciclovir (10 mg/ml) | > 240 minutes |
| 17. | Gemcitabine (Gemzar) (38 mg/ml) | > 240 minutes |
| 18. | Idarubicin (1 mg/ml) | > 240 minutes |
| 19. | Ifosfamide (50.0 mg/ml) | > 240 minutes |
| 20. | Irinotecan (20.0 mg/ml) | > 240 minutes |
| 21. | Mechlorethamine HCl (1.0 mg/ml) | > 240 minutes |
| 22. | Melphalan (5 mg/ml) | > 240 minutes |
| 23. | Methotrexate (25 mg/ml) | > 240 minutes |
| 24. | Mitoxantrone (2.0mg/ml) | > 240 minutes |
| 25. | Mitomycin C (0.5 mg/ml) | > 240 minutes |
| 26. | Oxaliplatin (5 mg/ml) | > 240 minutes |
| 27. | Paclitaxel (Taxol) (6.0 mg/ml) | > 240 minutes |
| 28. | Rituximab (10 mg/ml) | > 240 minutes |
| 29. | Thiotepa (10.0 mg/ml) | > 240 minutes |
| 30. | Trisenox (0.1 mg/ml) | > 240 minutes |
| 31. | Vincristine Sulfate (1.0 mg/ml) | > 240 minutes |
| 32. | Vinorelbine (10 mg/ml) | > 240 minutes |
Detection Time in Minutes
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- Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Z Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left and a white hexagon on the right. Inside the pink circle are four horizontal white lines. Inside the white hexagon are the letters "H" and "G" in blue.
HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: +66 74 536 815 Fax: +66 74 536 816
510(k) SUMMARY Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
1.0 Submitter:
| Applicant: | Healthy Glove Co., Ltd119 Kanchanavanich Road, Tambol PatongHat Yai, Songkhla 90230Thailand |
|---|---|
| Phone Number: | +66 74 536 815 |
| Fax Number: | +66 74 536 816 |
| Name of Contact Person: | Choh-Shee Teoh (Mr) |
| Preparation date: | November 24, 2016 |
2.0 Name of Subject Device:
| Trade/Proprietary Name(s): | HG PRO® XP Nitrile Powder Free Examination Gloves Tested for Usewith Chemotherapy Drugs |
|---|---|
| Common Name: | Nitrile Powder Free Examination Gloves Tested for Use withChemotherapy Drugs |
| Classification Name: | Patient Examination Gloves (21 CFR 880.6250) |
| Device Class: | I |
| Product Code: | LZA, LZC |
3.0 Identification of The Legally Marketed Devices that equivalency is claimed
| Manufacturer: | Kimberly Clark Corporation |
|---|---|
| Device Name: | PURPLE NITRILE-XTRA* Powder-Free Exam - 12' Length |
| 510(k): | K113423 |
| Regulatory Class: | I |
| Classification Name: | Patient Examination Gloves (21 CFR 880.6250) |
| Product Code: | LZA, LZC |
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Image /page/5/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left with horizontal lines inside, and a white hexagon on the right with the letters "HG" in blue. The text "SRITONG GROUP" is written in a bold, blue font below the logo.
4.0 Description of the Device:
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are non-sterile, lavender blue colored, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Chemotherapy drugs listed in the Intended Use(s) section below, as per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.
5.0 Intended Use of the Device:
A powder-free 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.
In addition, these gloves were tested for use with the following chemotherapy drugs at specific concentrations as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The gloves have been tested with the following drugs and the respective breakthrough detection times are listed below.
| No. | Chemotherapy Drugs | Concentration | Breakthrough detection timein Minutes |
|---|---|---|---|
| 1. | Blenoxane | 15 mg/ml | >240 min |
| 2. | Busulfan | 6 mg/ml | >240 min |
| 3. | Carboplatin | 10 mg/ml | >240 min |
| 4. | Carmustine (BCNU) * | 3.3 mg/ml | 30.4 min |
| 5. | Cisplatin | 1.0 mg/ml | >240 min |
| 6. | Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 min |
| 7. | Cytarabine | 100 mg/ml | >240 min |
| 8. | Dacarbazine (DTIC) | 10.0 mg/ml | >240 min |
| 9. | Daunorubicin | 5 mg/ml | >240 min |
| 10. | Docetaxel | 10.0 mg/ml | >240 min |
| 11. | Doxorubicin Hydrochloride | 2.0 mg/ml | >240 min |
| 12. | Ellence | 2 mg/ml | >240 min |
| 13. | Etoposide (Toposar) | 20.0 mg/ml | >240 min |
| 14. | Fludarabine | 25 mg/ml | >240 min |
| 15. | Fluorouracil | 50.0 mg/ml | >240 min |
| 16. | Ganciclovir | 10 mg/ml | >240 min |
| 17. | Gemcitabine (Gemzar) | 38 mg/ml | >240 min |
| 18. | ldarubicin | 1 mg/ml | >240 min |
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Image /page/6/Picture/0 description: The image shows a logo with two pink circles overlapping each other. The left circle contains four horizontal white lines. The right circle contains a white hexagon with the letters "HG" in blue. The text "SRITONG GROUP" is below the logo.
HEALTHY GLOVE CO., L
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: +66 74 536 815 Fax: +66 74 536 816
SRITONG GROUP
| No. | Chemotherapy Drugs | Concentration | Breakthrough detection timein Minutes |
|---|---|---|---|
| 19. | Ifosfamide | 50.0 mg/ml | >240 min |
| 20. | Irinotecan | 20.0 mg/ml | >240 min |
| 21. | Mechlorethamine HCl | 1.0 mg/ml | >240 min |
| 22. | Melphalan | 5 mg/ml | >240 min |
| 23. | Methotrexate | 25 mg/ml | >240 min |
| 24. | Mitoxantrone | 2.0mg/ml | >240 min |
| 25. | Mitomycin C | 0.5 mg/ml | >240 min |
| 26. | Oxaliplatin | 5 mg/ml | >240 min |
| 27. | Paclitaxel (Taxol) | 6.0 mg/ml | >240 min |
| 28. | Rituximab | 10 mg/ml | >240 min |
| 29. | Thiotepa | 10.0 mg/ml | >240 min |
| 30. | Trisenox | 0.1 mg/ml | >240 min |
| 31. | Vincristine Sulfate | 1.0 mg/ml | >240 min |
| 32. | Vinorelbine | 10 mg/ml | >240 min |
6.0 Summary of Technological Characteristics Compared to the Predicate Device:
There are no different technological characteristics of the Subject Device compared to the Predicate Device.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM D 6319 or equivalent standards as shown in Table 1.
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Image /page/7/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping pink circles. The left circle contains horizontal white lines, and the right circle contains a white hexagon with the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.
HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: +66 74 536 815 Fax: +66 74 536 816
Table 1. Side-by-Side Comparison of Predicate Device with Subject Device:
Indications for Use, Non-clinical Performance Data and Technological Characteristics
| Characteristics | AcceptanceCriteria/Standards | Predicate Device:510K No: 113423Non-Sterile, Powder Free NitrileExamination glove, Tested foruse with Chemotherapy drugsper ASTM D6978-05 | Subject Device:(New 510(k) submission)Non-Sterile, Powder Free NitrileExamination glove, Tested for usewith Chemotherapy drugs perASTM D6978-05 |
|---|---|---|---|
| Manufacturer(s) | Kimberly Clark Corporation | Healthy Glove Co., Ltd | |
| Indications for Use | Medical Gloves GuidanceManual | A powder-free patientExamination Gloves is adisposable device intended formedical purposes that is wornon the examiner's hand or fingerto prevent contaminationbetween patient and examiner | A powder-free patientExamination Gloves is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber | Nitrile Synthetic Rubber |
| Color | Purple | Lavender Blue | |
| Texture | Textured Fingers | Textured Fingers | |
| Size | Medical Glove GuidanceManual-Labeling- Issuedon January 22, 2008 | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large |
| Single Use | Medical Gloves GuidanceManual -Issued onJanuary 22, 2008 | Single use | Single use |
| Characteristics | AcceptanceCriteria/Standards | Predicate Device:510K No: 113423Non-Sterile, Powder Free NitrileExamination glove, Tested foruse with Chemotherapy drugsper ASTM D6978-05 | Subject Device:(New 510(k) submission)Non-Sterile, Powder Free NitrileExamination glove, Tested foruse with Chemotherapy drugsper ASTM D6978-05 |
| Dimension | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Length : 270 mm minimum | |||
| Palm Width | |||
| Extra Small = 70 +10 mmSmall = 80 +10 mmMedium = 95 +10 mmLarge = 110 +10 mmExtra Large = 120 ±10 mm | |||
| Thickness | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Finger: 0.10 mm minimum | |||
| Palm: 0.10 mm minimum | |||
| Physical Properties | ASTM D6319-10 | Meet ASTM D6319-10 | Meet ASTM D6319-10 |
| Tensile Strength: | |||
| 14 MPa min (before aging) | |||
| 14 MPa min (after aging) | |||
| Ultimate Elongation: | |||
| 500% min (before aging) | |||
| 400% min (after aging) | |||
| Watertight test(1000 ml) | ASTM D5151-06 | Pass | Pass AQL 1.5 |
| Residual Powder | ASTM D6124-06 | Meet< 2.0 mg/glove | Meet< 2.0 mg/glove |
| Biocompatibility | Primary Skin Irritation -ISO 10993-10: 2010 | Pass | PassNot a primary skin irritant underthe conditions of the study |
| Dermal Sensitization -ISO 10993-10: 2010 | Pass | PassNot a contact sensitizer underthe conditions of the study | |
| Characteristics | AcceptanceCriteria/Standards | Predicate Device:510K No: 113423Non-Sterile, Powder FreeNitrile Examination glove,Tested for use withChemotherapy drugs perASTM D6978-05 | Subject Device:(New 510(k) submission)Non-Sterile, Powder FreeNitrile Examination glove,Tested for use withChemotherapy drugs perASTM D6978-05 |
| Resistance againstChemotherapy Drugs | ASTM D6978-05(2013) | Breakthrough Detection Time (min) | |
| Blenoxane(15 mg/ml) | Not tested | > 240 min | |
| Busulfan(6 mg/ml) | > 240 min | > 240 min | |
| Carboplatin(10 mg/ml) | > 240 min | > 240 min | |
| Carmustine (BCNU) *(3.3 mg/ml) | 30.7 min | 30.4 min | |
| Cisplatin(1.0 mg/ml) | > 240 min | > 240 min | |
| Cyclophosphamide(Cytoxan)(20 mg/ml) | > 240 min | > 240 min | |
| Cytarabine100 mg/ml | > 240 min | > 240 min | |
| Dacarbazine (DTIC)(10.0 mg/ml) | > 240 min | > 240 min | |
| Daunorubicin(5 mg/ml) | > 240 min | > 240 min | |
| Docetaxel(10.0 mg/ml) | > 240 min | > 240 min | |
| DoxorubicinHydrochloride(2.0 mg/ml) | > 240 min | > 240 min | |
| Ellence(2 mg/ml) | > 240 min | > 240 min | |
| Etoposide (Toposar)(20.0 mg/ml) | > 240 min | > 240 min | |
| Fludarabine(25 mg/ml) | > 240 min | > 240 min | |
| Fluorouracil(50.0 mg/ml) | > 240 min | > 240 min | |
| Ganciclovir(10 mg/ml) | Not tested | > 240 min | |
| Gemcitabine (Gemzar)(38 mg/ml) | > 240 min | > 240 min | |
| Idarubicin(1 mg/ml) | > 240 min | > 240 min | |
| Ifosfamide(50.0 mg/ml) | > 240 min | > 240 min | |
| Irinotecan(20.0 mg/ml) | > 240 min | > 240 min | |
| Mechlorethamine HCl(1.0 mg/ml) | > 240 min | > 240 min | |
| Characteristics | AcceptanceCriteria/Standards | Predicate Device:510K No: 113423Non-Sterile, Powder FreeNitrile Examination glove,Tested for use withChemotherapy drugs perASTM D6978-05 | Subject Device:(New 510(k) submission)Non-Sterile, Powder FreeNitrile Examination glove,Tested for use withChemotherapy drugs perASTM D6978-05 |
| Resistance againstChemotherapy Drugs | ASTM D6978-05(2013) | Breakthrough Detection Time (min) | |
| Melphalan(5 mg/ml) | > 240 min | > 240 min | |
| Methotrexate(25 mg/ml) | > 240 min | > 240 min | |
| Mitoxantrone(2.0mg/ml) | > 240 min | > 240 min | |
| Mitomycin C(0.5 mg/ml) | > 240 min | > 240 min | |
| Oxaliplatin(5 mg/ml) | Not tested | > 240 min | |
| Paclitaxel (Taxol)(6.0 mg/ml) | > 240 min | > 240 min | |
| Rituximab(10 mg/ml) | > 240 min | > 240 min | |
| Thiotepa(10.0 mg/ml) | > 240 min | > 240 min | |
| Trisonex(0.1 mg/ml) | > 240 min | > 240 min | |
| Vincristine Sulfate(1.0 mg/ml) | > 240 min | > 240 min | |
| Vinorelbine(10 mg/ml) | Not tested | > 240 min | |
| Please note that the followingdrug has extremely lowpermeation times: | *Please note that thefollowing drug has extremelylow permeation times: | ||
| Carmustine (BCNU) (3.3mg/ml) 30.7 minutes | Carmustine (BCNU) (3.3mg/ml) at 30.4 minutes |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows a logo for the Sritong Group. The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.
HEALTHY GLOVE CO., LTD.
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: +66 74 536 815 Fax: +66 74 536 816
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows a logo for SRITONG GROUP. The logo consists of two pink circles that are overlapping. The left circle contains four horizontal white lines. The right circle contains a white hexagon with the letters 'HG' in blue. The text 'SRITONG GROUP' is located below the logo.
HEALTHY GLOVE CO., LTD.
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand
Tel: +66 74 536 815 Fax: +66 74 536 816
SRITONG GROUP
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo.
HEALTHY GLOVE CO.,
119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: +66 74 536 815 Fax: +66 74 536 816
7.0 Substantial Equivalent Based on Assessment of Non-clinical Performance Data:
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements).
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
No clinical testing was required to determine substantial equivalence of this device.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" inside of a hexagon. The text "SRITONG GROUP" is written in blue below the logo.
HEALTHY GLOVE CO., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: +66 74 536 815 Fax: +66 74 536 816
9.0 Conclusion:
Based on the comparison of the intended use, technological characteristics and non-clinical performance test data, the subject device, Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs is substantially equivalent to the Predicate Device K113423.
§ 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.