(85 days)
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. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.
This document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile, with Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim. The submission seeks to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-11; ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-11; ASTM D 6319-10 | Meets |
| Low Dermatitis Potential (Biocompatibility) | Modified Draize-95 Test (as per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999") | No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects. Results of the human repeat insult patch test (HRIPT) on 200 subjects were negative, indicating no potential for inducing dermal irritation or sensitization in the general user population. |
| Dermal Sensitization (Biocompatibility) | ISO 10993-10:2010 | Not a contact skin sensitizer |
| Primary Skin Irritation Test (Biocompatibility) | 16 CFR Part 1500.41 | Not a primary skin irritant |
| Chemotherapy Drugs Permeation Test | ASTM D6978-05 | Dacarbazine (DTIC) (10.0 mg/ml): > 240 minutes Carmustine (BCNU) (3.3 mg/ml): 15.3 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml): > 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes Fluorouracil (50.0 mg/ml): > 240 minutes Cisplatin (1.0 mg/ml): > 240 minutes Etoposide (20.0 mg/ml): > 240 minutes Paclitaxel (Taxol) (6.0 mg/ml): > 240 minutes Thiotepa (10.0 mg/ml): 195.8 minutes |
2. Sample size used for the test set and the data provenance
- Low Dermatitis Potential (Modified Draize-95 Test):
- Sample Size: A total of 200 human subjects.
- Data Provenance: Prospective, clinical study. The document states, "The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested... The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage..."
- Country of Origin: Not explicitly stated, though the submitter is based in Malaysia. The study aimed to reflect "the general user population in the US."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the Modified Draize-95 Test or the Chemotherapy Drugs Permeation Test. These tests are standardized laboratory and human subject tests, respectively, where the "ground truth" is determined by the specific criteria and readings of the test methods rather than expert consensus on subjective findings.
4. Adjudication method for the test set
The document does not describe an adjudication method for the tests performed. For the human subject testing (Modified Draize-95), the results were simply "all negative," indicating no ambiguous findings requiring adjudication. For the other performance tests (e.g., dimensions, physical properties, pinholes, powder residue, chemotherapy permeation), the results are quantitative or pass/fail against established 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical glove, and the nature of its evaluation does not involve human readers interpreting data or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used
- For physical properties, pinholes, and powder free residue: Ground truth was established by adherence to recognized ASTM (American Society for Testing and Materials) standards (ASTM D6319-10, ASTM D5151-11, ASTM D6124-11), which define objective test methods and acceptance criteria.
- For biocompatibility (dermal sensitization and primary skin irritation): Ground truth was established by adherence to ISO 10993-10:2010 and 16 CFR Part 1500.41, which are standardized testing protocols for biological evaluation of medical devices.
- For Low Dermatitis Potential: Ground truth was established through a human clinical study (Modified Draize-95 Test) observing the absence of allergic or irritant reactions in human subjects.
- For Chemotherapy Drugs Permeation Test: Ground truth was established by adherence to the ASTM D6978-05 standard, which outlines specific methods for measuring drug permeation through protective materials.
8. The sample size for the training set
This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This is not applicable as the device is a medical glove and does not involve machine learning or AI models with training sets.
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Image /page/0/Picture/0 description: The image shows the logo for Kossan Latex Industries. The logo includes the letters "KL1" in a bold, black font on the left side of the image. To the right of the letters, the text "KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)" is displayed in a smaller, serif font.
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
1.0 Submitter:
Kossan Latex Industries (M) Sdn Bhd Lot 6129, Jalan Haji Abdul Manan, Batu 5 1/4, Jalan Meru, Klang, 41050 Selangor, Malaysia
Telephone No .: +603 3392 3088 Fax No .: +603 3291 0584
2.0 Contact Person:
| Contact: | Ms S F Cho |
|---|---|
| Telephone No.: | +603 3392 3088 |
| Fax No.: | +603 3291 0584 |
3.0 Preparation Date: 29 November 2012
4.0 Name of Device:
Trade Name: Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim.
Powder-Free Nitrile Patient Examination Glove Common Name: Classification Name: Patient Examination Glove (21 CFR Part 880.6250) Regulatory Class: Class I Product Code: 80 LZC, 80 LZA.
5.0 Identification of the Legally Marketed Device:
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim; Class I Patient Examination Gloves, Nitrile-80LZA, 80LZC, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Predicate Device: K120066, Powder Free Nitrile Patient Examination Glove, Blue, White, Green. Non-Sterile. Low Dermatitis Potential Labeling Claim.
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K L 1 KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)
6.0 Description of Device:
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.
7.0 Intended Use of the Device:
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.
This glove has been tested for use with specific chemotherapy drugs listed below.
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.3 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 195.8 |
Warning: Do not use with Carmustine.
8.0 Summary of the Technological Characteristics of the Device:
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim possess the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-holes | ASTM D 5151-11 | Meets |
| ASTM D 6319-10 | Meets | |
| Powder Free Residue | ASTM D 6124-11 | Meets |
| ASTM D 6319-10 | Meets | |
| Biocompatibility | Dermal Sensitization(as per ISO 10993-10:2010) | Not a contact skin sensitizer |
| Primary SkinIrritation Test(as per 16 CFR Part1500.41) | Not a primary skin irritant |
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)
| Characteristic | Standards | Device Performance | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low DermatitisPotential | Modified Draize-95 Test | No clinical evidence presence of residualchemical additives that may induce TypeIV allergy in human subjects. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Chemotherapy DrugsPermeation Test | ASTM D6978-05 | Chemotherapy Drug Permeation(Minimum Breakthrough Detection Timein Minutes) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dacarbazine (DTIC) (10.0 mg/ml) and the corrected html is: ```html Characteristic Standards Device Performance Low DermatitisPotential Modified Draize-95 Test No clinical evidence presence of residualchemical additives that may induce TypeIV allergy in human subjects. Chemotherapy DrugsPermeation Test ASTM D6978-05 Chemotherapy Drug Permeation(Minimum Breakthrough Detection Timein Minutes) Dacarbazine (DTIC) (10.0 mg/ml) Carmustine (BCNU) (3.3 mg/ml) Cyclophosphamide (Cytoxan)(20.0 mg/ml) Doxorubicin Hydrochloride(2.0 mg/ml) Fluorouracil (50.0 mg/ml) Cisplatin (1.0 mg/ml) Etoposide (20.0 mg/ml) Paclitaxel (Taxol) (6.0 mg/ml) Thiotepa (10.0 mg/ml) > 240 15.3 > 240 > 240 > 240 > 240 > 240 > 240 195.8 |
9.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Testing was performed per ASTM D6319-10, ASTM D5151-11, ASTM D6124-11, ISO 10993-10:2010, and 16 CFR Part 1500.41. The gloves meet standard requirements referenced in Section 8.0 above. Biocompatibility test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant.
Substantial Equivalent Based on Assessment of Clinical Performance Data 10.0
Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products, 1999".
The study was conducted in two stages. In the first stage, a population of 50 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum of 200 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability.
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K L 1 KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)
The study completed on 200 non-sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce Type IV allergy in the un-sensitized general user population in the tested article.
11.0 Conclusion
It can be concluded that Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim is safe and effective for use, and perform according to the glove performance standards referenced in Section 8.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
This device is identical and substantially equivalent to currently marketed devices, per Substantial Equivalence Comparison Table below:-
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K) KLI
Substantial Equivalence Comparison Table
| Featur | (120066, Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterent Colored, Non-SterenPredicate Device | Powder Free Nitrile Patient Examination Glovential Chemotherapy Drugs Protection Labeling Cla |
|---|---|---|
| tended U | Proposed Devicedentica | |
| ications for Us | ntended for medical purposes that is worn on the | patient examination glove is a disposable device ended for medical purposes that is worn on theent and examiner. I glove has been tested for use with specifichemotherapy drugs listed below |
| なお気になる8 556 Obizisaearbazine (DZTIC) ( 0.0 mg/mL) velophosphamide ( ( 10.0 mg/mL) velophosphamide ( ( 10.0 mg/mL) velophosphamide ( ( 10.0 mg/mL) velophosille ( 1) video ( ( 12.0 mg/mL) 1nemotherapy Drug Permeation (Minimutes | ||
| arning: Do not use with Carmu |
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KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K) KLI
| Feature | K120066, Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile (Low Dermatitis Potential Labeling Claim) of Kossan Latex Industries Sdn Bhd | Predicate Device | Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim |
|---|---|---|---|
| Material | Nitrile | Blue, White and Green | Proposed Device Identical |
| Color | Yes | Green | Identical |
| Single Use | Yes | Yes | Identical |
| Sterilization | Not Applicable; Non-Sterile | Not Applicable; Non-Sterile | Identical |
| Dimensions | Meets ASTM D6319 | Meets ASTM D6319 | Identical |
| Physical Properties | Meets ASTM D6319 | Meets ASTM D6319 | Identical |
| Freedom from Pinholes | Meets ASTM D5151 and ASTM D6319 | Meets ASTM D5151 and ASTM D6319 | Identical |
| Residue Powder | Meets ASTM D6124 and ASTM D6319 | Meets ASTM D6124 and ASTM D6319 | Identical |
| Biocompatibility Test | Pass Dermal Sensitization Test Pass Primary Skin Irritation Test | Pass Dermal Sensitization Test Pass Primary Skin Irritation Test | Identical |
| Human Draize Test | Pass | Pass | Identical |
| Chemotherapy Drugs Permeation Test | Not Applicable; Not Tested | Not Applicable; Not Tested | Meets ASTM D6978-05 |
| Labeling Claim | Low Dermatitis Potential Labeling Claim | Low Dermatitis Potential Labeling Claim | Proposed device With Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a stylized graphic on the right and a circular arrangement of text on the left. The graphic resembles a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Ms. Cho Sow Fong Manager, Regulatory Affairs Kossan Latex Industries (M) Sdn Bhd Lot 16632, 51/4 Miles, Jalan Meru Klang Selangor, Malaysia 41050
Re: K123749
Trade/Device Name: Powder Free Nitrile Examination Gloves, Green, Non Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Labeling Claim.
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA. LZC Dated: January 21, 2013 Received: January 25, 2013
Dear Ms. Fong:
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.
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Page 2 - Ms. Fong
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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Anthony D. Watson, B.S., M.S., M.B.A. 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): K123749
Device Name:
Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile. Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Labeling Claim.
Indications for 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. This glove has been tested for use with specific chemotherapy drugs listed below,
Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)
| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.3 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 195.8 |
Please note that Carmustine has extremely low permeation times of 15.3 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) x
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabeth-F.Claverie
2013.02.27 17:10:04 -05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Anesu.co.org/w/infection Control
510(k) Number,
Page 1 of _
§ 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.