(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 Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs. Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.
The device, "Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)," demonstrated compliance through a series of non-clinical performance studies. The studies assessed the gloves against various ASTM standards and internal performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3578-01E1 | Meets |
| Physical Properties | ASTM D3578-01E1 | Meets |
| Thickness | ASTM D3578-01E1 | Meets |
| Powder Free | ASTM D6124-01 | Meets (≤ 2 mg/glove) |
| Protein Level | ASTM D5712-95 | Meets (< 50 µg/g) |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation | Passes (Not a primary skin irritant) |
| Biocompatibility: Dermal Sensitization | 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 sample sizes used for each specific test (e.g., dimensions, physical properties, thickness, powder free, protein level, biocompatibility, watertight, or chemotherapy drug permeation). It references ASTM standards for these tests, which typically specify sample size requirements.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer, WRP Asia Pacific Sdn Bhd, in Malaysia. The studies were non-clinical, and it is implied they were conducted in-house or by accredited labs following the referenced ASTM standards. The data is retrospective in the sense that results from these tests are being presented for regulatory review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a non-clinical device (gloves) and the "ground truth" is established by adherence to recognized ASTM performance standards and laboratory test results, not by expert medical opinion or diagnostic accuracy.
4. Adjudication Method for the Test Set
N/A. This is a non-clinical device. Test results are objective measurements against defined standard criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This is a non-clinical device (examination gloves). MRMC studies are typically performed for diagnostic or AI-assisted interpretation devices where human interpretation is involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This device is not an algorithm or AI system. Its performance is assessed through physical and chemical testing.
7. Type of Ground Truth Used
The "ground truth" for this device is established by:
- ASTM Standard Specifications: Adherence to established and recognized American Society for Testing and Materials (ASTM) standards for physical properties, dimensions, thickness, powder content, protein levels, and watertight integrity.
- Laboratory Test Results: Objective measurements and observations from tests conducted according to these ASTM standards (e.g., protein content measurement, permeation studies for chemotherapy drugs, biocompatibility tests).
8. Sample Size for the Training Set
N/A. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for this type of device, this question is not applicable.
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JUL 3 1 2009
Appendix B
510(K) summary Page 1 of 3
510(k) SUMMARY
1.0 Submitter:
| Name: | Mr. Kirk Penner |
|---|---|
| Address: | WRP Asia Pacific Sdn BhdLot 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
Name of the device: 2.0
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein)
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:
Oncology Plus Powder-Free Latex Examination Gloves (Protein Content Labeling, 50 micrograms or less) Regulatory Class I Product code: LYY 510(k): K972616
4.0 Description of The Device:
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein} meet all the requirements of ASTM standard D6978-05, D5712-054 and FDA 21 CFR 880.6250.
Intended Use of the Device: 5.0
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 [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]
WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
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Appendix B
510(K) summary Page 2 of 3
510(k) SUMMARY
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein) are summarized with the following technological characteristics compared to ASTM D3578-01E4 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE(Both Predicate andCurrent) |
|---|---|---|
| Dimensions | ASTM D3578-01E1 | Meets |
| Physical Properties | ASTM D3578-01E1 | Meets |
| Thickness | ASTM D3578-01E1 | Meets |
| Powder Free | ASTM D6124-01 | Meets≤ 2 mg/glove |
| Protein Level | ASTM D5712-95 | Meets< 50 µg/g |
| Biocompatibility | Primary SkinIrritation | Passes(Not a primary skin irritant) |
| Dermal SensitizationASTM F-720-81 | Passes(Not a contact sensitizer) | |
| Watertight (1000ml) | ASTM D5151-06 | Passes |
| CHARACTERISTICS | Predicate Device(K972615) | Current device |
|---|---|---|
| Resistance to permeationby Chemotherapy Drugs | Tested to ASTMF739-91Meets requirement | ASTM D6978-05Meets requirement |
*Details and discussions of tests can be found in the performance section.
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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KD83410
Appendix B
510(k) SUMMARY
510(K) summary Page 3 of 3
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 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 Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50μg/dm² per glove of extractable protein) 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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JUL 31 2009
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 43900 Sepang Selangor Darul Ehsan MALAYSIA
Re: K083410
Trade/Device Name: Powder Free Latex Patient Examination Gloves, Tested For Use With Chemotherapy Drugs With a Protein Content Label Claim (<50ug/dm2 Per Glove of Extractable Protein)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LZC, LYY
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); labeling (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 i 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 Renner
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 A
Asia Pacific San Bha
Salak Tinggi Darbitt
260 - 3 - 8 7 36 1 55
Indications for Use
510(k) Number (if known): K083410
Applicant Name: WRP ASIA PACIFIC SDN BHD
Device Name:
Powder Free Latex Patient Examination Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim (≤50µg/dm² per glove of extractable protein)
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 Tested chemotherapy drugs are as follows [Cyclophosphamide, drugs. Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel]
WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND 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)
Your Partner In Protection™
Shule A Murphy to
(Division Sign-Off) the image shows a signature and the words "Page of"
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.