(255 days)
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.
Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs," based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-00a | Meets |
| Physical Properties | ASTM D6319-00a | Meets |
| Thickness | ASTM D6319-00a | Meets |
| Powder Free | ASTM D6124-01 | Meets (≤ 2 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | - (Implied standard) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ASTM F-720-81 | Passes (Not a contact sensitizer) |
| Watertight (1000ml) | ASTM D5151-06 | Passes |
| Resistance to permeation by Chemotherapy Drugs | ASTM D6978-05 | Meets requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (dimensions, physical properties, etc.). However, it refers to ASTM standards, which typically outline sampling plans.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied the testing was conducted by the manufacturer (WRP Asia Pacific Sdn Bhd in Malaysia) to meet international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics of examination gloves is established through objective physical and chemical testing against recognized industry standards (e.g., ASTM standards), not through expert consensus or interpretation of medical images/data.
4. Adjudication Method for the Test Set
This information is not applicable as there were no subjective assessments requiring adjudication. The tests conducted are objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This device is an examination glove, which does not involve human interpretation in the same manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was conducted. The device (the glove) itself was tested against the various ASTM standards and performance criteria. There is no "algorithm" or "human-in-the-loop" component in the functionality of an examination glove beyond its intended physical properties.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is based on objective, standardized measurements and criteria defined by established industry standards (ASTM). For example:
- Physical measurements (dimensions, thickness)
- Chemical analysis (powder content)
- Biocompatibility assays (skin irritation, sensitization)
- Barrier integrity tests (watertightness, chemotherapy drug permeation)
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML-based system that requires a "training set" in the conventional sense. The manufacturing process and quality control would involve ongoing testing, but there isn't a "training set" like there would be for an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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K08 3408
Appendix E
JUL 3 1 2009
510(K) summary Page 1 of 3
510(k) SUMMARY
1.0 Submitter:
| Name: | Mr. Kirk Penner |
|---|---|
| Address: | WRP Asia Pacific Sdn Bhd |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, | |
| 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: July 2008
2.0 Name of the device:
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs
Common Name: Exam Gloves
Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 product code LZC)
3.0 Identification of The Legally Marketed Devices:
Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves Non-Sterile (Tested For use With Chemotherapy Drug) Labeling Claim Regulatory Class I Product code: LYY 510(k): K002064
4.0 Description of The Device:
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.
5.0 Intended Use of the Device:
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested follows [Carmustine (BiCNU), Thip-Tepa. chemotherapy drugs are as Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; ຜ່າ Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA
CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
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Appendix E
510(K) summary Page 2 of 3
510(k) SUMMARY
Summary of the Technological Characteristics of the Device: 6.0
The Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs are summarized with the following technological characteristics compared to ASTM D3578-0151 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE(Both Predicate andCurrent) |
|---|---|---|
| Dimensions | ASTM D6319-00a | Meets |
| Physical Properties | ASTM D6319-00a | Meets |
| Thickness | ASTM D6319-00a | Meets |
| Powder Free | ASTM D6124-01 | Meets≤ 2 mg/glove |
| Biocompatability | Primary SkinIrritation | Passes(Not a primary skin irritant) |
| Dermal SensitizationASTM F-720-81 | Passes(Not a contact sensitizer) | |
| Watertight (1000ml) | ASTM D5151-06 | Passes |
*Details and discussions of tests can be found in performance section
| CHARACTERISTICS | Predicate Device(K972615) | Current device |
|---|---|---|
| Resistance to permeationby Chemotherapy Drugs | Tested to ASTMF739-91Meets requirement | ASTM D6978-05Meets requirement |
All other characteristics including appearance, thickness, material, psychical properties are equivalent to the predicate device. There is essentially no change to the device. This 510(k) submission is to seek approval for the device to be marketed with the ASTM D6978-05 claim on resistance to permeation by chemotherapy drugs.
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K08 3408
Appendix E
510(K) summary Page 3 of 3
510(k) SUMMARY
Substantial Equivalent Based on Assessment of Non-Clinical Performance 7.0 Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is substantially equivalent to currently marketed devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kirk Penner Head of Department, Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi 49300 Sepang Selangor Darul Ehsan MALAYSIA
JUL 3 1 2009
Re: K083408
Trade/Device Name: Powder Free Blue Nitrile Patient Examination Gloves, Tested For Use With Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LZC, LZA
Dated: June 25, 2009
Received: July 1, 2009
Dear Mr. Penner:
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.
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 - Mr. Penner
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); fabeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Rumer
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix D
WRP Asia Pacific Sdn Bhd
l of 1 Jalan 3 Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepano. Selangor Darul Ehsan MALAYSIA
Office 60-3-8706 1486 +60-3-8706 1957 customer_wrp@wroworld.co Website www.wipworld.com
Indications for Use
510(k) Number (if known): K083408
Applicant Name: WRP ASIA PACIFIC SDN BHD
Device Name:
Powder Free Blue Nitrile Patient Examination Gloves, tested for use with Chemotherapy Drugs
Indications for Use:
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
Prescription Use No (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use YES (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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§ 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.