(253 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 [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE
Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 and FDA 21 CFR 880.6250.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Blue Latex Patient Examination Gloves:
This document is a 510(k) summary for a medical device (examination gloves), which primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards. Therefore, the "study" described is a series of compliance tests rather than a clinical trial or a typical algorithmic performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | Acceptance Criteria (Standards) | Reported Device Performance (Current Device) |
|---|---|---|
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Thickness | ASTM D3578-05 | Meets |
| Powder Free | ASTM D6124-06 | Meets (< 2 mg/glove) |
| Protein Level | ASTM D5712-05e1 | Meets (< 50 $\mu$g/g) |
| Biocompatibility (Primary Skin Irritation) | Not explicitly stated standard, but implied test | 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 sample sizes used for each individual test (e.g., how many gloves were tested for dimensions, watertightness, etc.). However, these are standard laboratory tests typically performed on a statistically significant sample of units from production batches according to the respective ASTM standards.
Data Provenance: The document does not specify the country of origin for the data, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. The tests are non-clinical, laboratory-based, and as such, are prospective in the sense that they are conducted specifically to demonstrate compliance with the standards for this submission, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable in the context of this device and study. The "ground truth" for examination gloves is defined by adherence to established, objective, and standardized performance criteria set forth by organizations like ASTM. The tests are quantifiable and measurable against these engineering standards, not through subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective and based on measurable parameters defined by ASTM standards. There is no need for human adjudication of results that are determined by laboratory measurements (e.g., a glove either meets the thickness specification or it doesn't).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or algorithms where human interpretation is a critical component and the AI's impact on human performance is being evaluated. This device is a physical barrier (glove), not an AI-powered diagnostic tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in a way. The performance evaluation is entirely "standalone" in the sense that it assesses the intrinsic physical and chemical properties of the glove itself against defined standards. There is no "algorithm" in the traditional sense, nor is there a human-in-the-loop interacting with a software component. The device's performance is its inherent characteristic, evaluated in isolation through laboratory testing.
7. Type of Ground Truth Used
The ground truth used is based on established engineering and performance standards (e.g., ASTM standards for dimensions, physical properties, watertightness, protein level, and chemical permeation resistance). Biocompatibility is assessed against pass/fail criteria for irritation and sensitization. These are objective, measurable criteria, not expert consensus, pathology, or outcomes data in the usual clinical sense.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (glove), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Appendix C
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 +60 3 8706 1485 Fax No.:
Date of Summary Prepared: July 2008
2.0 Name of the device:
Powder Free Blue 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)
510(k) K083409
3.0 Identification of The Legally Marketed Devices:
Chemoplus Powder Free Blue latex Examination Gloves with Protein Labeling Claim 50 Micrograms or less. Regulatory Class I Product code: LYY 510(k): K972615
4.0 Description of The Device:
Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 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 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
{1}------------------------------------------------
Appendix C
510(K) summary Page 2 of 3
510(k) SUMMARY
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Blue 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 D3578-05 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE(Both Predicate andCurrent) |
|---|---|---|
| Dimensions | ASTM D3578-05 | Meets |
| Physical Properties | ASTM D3578-05 | Meets |
| Thickness | ASTM D3578-05 | Meets |
| Powder Free | ASTM D6124-06 | Meets< 2 mg/glove |
| Protein Level | ASTM D5712-05e1 | Meets< 50 $ \mu $ g/g |
| 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 |
| CHARACTERISTICS | Predicate Device(K972615) | Current device |
|---|---|---|
| Resistance to permeationby Chemotherapy Drugs | Tested to ASTMF739-91 | ASTM D6978-05 |
| Meets requirement | Meets 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.
{2}------------------------------------------------
KD83409
Appendix C
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.
Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
Powder Free Blue 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.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three lines representing the wings and legs.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 2009
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
Re: K083409
Trade/Device Name: Powder Free Blue 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, 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.
{4}------------------------------------------------
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 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.
Antony D. Winter for
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
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the letters "VWRP" in a bold, sans-serif font. The letters are black and have a slightly textured appearance. The letters are arranged horizontally, with the "V" being the largest and the "P" being the smallest.
Appendix
WRP Asia Pacific Sdn Bhd
Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Safak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSI A
Office 460-3-8706 1486 FacsImile +60-3-8706 1557 Email customer_wrp@wrpworld.com www.wrpworld.com Website
Indications for Use
510(k) Number (if known): K083409
Applicant Name: WRP ASIA PACIFIC SDN BHD
Device Name:
Powder Free Blue 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
(21 CFR 801 Subpart C)
YES
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K083409 |
| Page | of |
| Your Partner In Protection" |
§ 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.