(160 days)
Not Found
No
The device is a physical examination glove and the summary describes its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No.
The device is a medical glove intended for protection and prevention of contamination, not for treating a disease or condition.
No
The device is a patient examination glove, which is a barrier device to prevent contamination, not a diagnostic tool.
No
The device is a physical medical device (examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is a "powder-free patient examination glove... to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Function: The device acts as a physical barrier. While it has been tested for resistance to chemotherapy drugs, this testing is to demonstrate its protective capabilities for the user, not to diagnose, monitor, or treat a disease or condition based on in vitro examination of specimens derived from the human body.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transplant tissues, organs or blood, or to monitor therapeutic measures. This glove does not fit this definition.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, watertightness, etc.) and its resistance to chemical permeation, all related to its function as a protective barrier. There are no studies related to analyzing biological specimens.
The testing for chemotherapy drug permeation is a specific performance characteristic of the glove, indicating its suitability for use in environments where these drugs are handled, but it does not change the fundamental nature of the device from a protective barrier to an IVD.
N/A
Intended Use / Indications for Use
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 |
- Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) at 30.4 minutes
Product codes
LZA, LZC
Device Description
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.
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's hand or finger
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for conformance to ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application) and ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Key results for ASTM D6319-10 are:
- Dimensions (Length, Palm Width): Meets ASTM D6319-10.
- Length: 270 mm minimum
- Palm Width: Extra Small = 70 ±10 mm, Small = 80 ±10 mm, Medium = 95 ±10 mm, Large = 110 ±10 mm, Extra Large = 120 ±10 mm
- Thickness: Meets ASTM D6319-10.
- Finger: 0.10 mm minimum
- Palm: 0.10 mm minimum
- Physical Properties: Meet ASTM D6319-10.
- Tensile Strength: 14 MPa min (before and after aging)
- Ultimate Elongation: 500% min (before aging), 400% min (after aging)
- Watertight test (1000 ml) (ASTM D5151-06): Pass AQL 1.5
- Residual Powder (ASTM D6124-06): Meet 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 (2.0mg/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
- Trisonex (0.1 mg/ml): > 240 min
- Vincristine Sulfate (1.0 mg/ml): > 240 min
- Vinorelbine (10 mg/ml): > 240 min
Biocompatibility testing (Primary Skin Irritation and Dermal Sensitization per ISO 10993-10: 2010): Pass, Not a primary skin irritant or contact sensitizer under the conditions of the study.
No clinical testing was required.
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.
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
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
1
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
2
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
3
- 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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., Ltd
119 Kanchanavanich Road, Tambol Patong
Hat Yai, Songkhla 90230
Thailand |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| 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 Use
with Chemotherapy Drugs |
|----------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Nitrile Powder Free Examination Gloves Tested for Use with
Chemotherapy 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 |
5
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 time
in 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 |
6
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 time
in 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.
7
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 | Acceptance
Criteria/Standards | Predicate Device:
510K No: 113423
Non-Sterile, Powder Free Nitrile
Examination glove, Tested for
use with Chemotherapy drugs
per ASTM D6978-05 | Subject Device:
(New 510(k) submission)
Non-Sterile, Powder Free Nitrile
Examination glove, Tested for use
with Chemotherapy drugs per
ASTM D6978-05 |
|---------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer(s) | | Kimberly Clark Corporation | Healthy Glove Co., Ltd |
| Indications 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 | 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 |
| Material | ASTM D6319-10 | Nitrile Synthetic Rubber | Nitrile Synthetic Rubber |
| Color | | Purple | Lavender Blue |
| Texture | | Textured Fingers | Textured Fingers |
| Size | Medical Glove Guidance
Manual-Labeling- Issued
on January 22, 2008 | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large |
| Single Use | Medical Gloves Guidance
Manual -Issued on
January 22, 2008 | Single use | Single use |
| Characteristics | Acceptance
Criteria/Standards | Predicate Device:
510K No: 113423
Non-Sterile, Powder Free Nitrile
Examination glove, Tested for
use with Chemotherapy drugs
per ASTM D6978-05 | Subject Device:
(New 510(k) submission)
Non-Sterile, Powder Free Nitrile
Examination glove, Tested for
use with Chemotherapy drugs
per 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 mm
Small = 80 +10 mm
Medium = 95 +10 mm
Large = 110 +10 mm
Extra 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
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 |
| Cytarabine
100 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 |
| Doxorubicin
Hydrochloride
(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 | Acceptance
Criteria/Standards | Predicate Device:
510K No: 113423
Non-Sterile, Powder Free
Nitrile Examination glove,
Tested for use with
Chemotherapy drugs per
ASTM D6978-05 | Subject Device:
(New 510(k) submission)
Non-Sterile, Powder Free
Nitrile Examination glove,
Tested for use with
Chemotherapy drugs per
ASTM D6978-05 |
| Resistance against
Chemotherapy 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 following
drug has extremely low
permeation times: | *Please note that the
following drug has extremely
low permeation times: |
| | | Carmustine (BCNU) (3.3
mg/ml) 30.7 minutes | Carmustine (BCNU) (3.3
mg/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.