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, Dacarbazine, Doxorubicin Hydrochloride; 5-Fluorouracil, Cisplatin, Etoposide, Vincristine Sulfate and Paclitaxel] WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

Device Description

Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim meet all the requirements of ASTM standard D6978-05, D5712-0562 and FDA 21 CFR 880.6250.

AI/ML Overview

This document describes the acceptance criteria and performance of "Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim." This device is a medical glove, and the study focuses on its physical properties, biocompatibility, watertightness, sterility, and critically, its resistance to permeation by chemotherapy drugs.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

CHARACTERISTICS	STANDARDS	ACCEPTANCE CRITERIA (implied by "Meets" or "Passes")	DEVICE PERFORMANCE (Both Predicate and Current)
Dimensions	ASTM D6319-00a (2005) e-1	Meets relevant ASTM D6319-00a dimension specifications	Meets
Physical Properties	ASTM D6319-00a (2005) e-1	Meets relevant ASTM D6319-00a physical property specifications	Meets
Thickness	ASTM D6319-00a (2005) e-1	Meets relevant ASTM D6319-00a thickness specifications	Meets
Powder Free	ASTM D6124-01	≤ 2 mg/glove	Meets (≤ 2 mg/glove)
Biocompatibility: Primary Skin Irritation	ASTM F-720-81	Not a primary skin irritant	Passes (Not a primary skin irritant)
Biocompatibility: Dermal Sensitization	ASTM F-720-81	Not a contact sensitizer	Passes (Not a contact sensitizer)
Watertight (1000ml)	ASTM D5151-06	Passes watertight test	Passes
Resistance to permeation by Chemotherapy Drugs	ASTM D6978-05	>240 minutes breakthrough detection time	Meets requirement (See detailed table below)
Sterile	Gamma Irradiated (SAL: 10-6)	Sterile (Dose Validation Report Attached)	Sterile (Dose Validation Report Attached)

Detailed Breakthrough Detection Time for Chemotherapy Drugs (per ASTM D6978-05):

Test Chemical and Concentration	Average breakthrough Detection Time (minutes)	Acceptance Criteria (from above table)
Dacarbazine 10mg/ml	>240	>240 minutes
Cyclophosphamide (Cytoxan) 20mg/ml	>240	>240 minutes
Doxorubicin Hydrochloride 2mg/ml	>240	>240 minutes
5-Flourouracil 50mg/ml	>240	>240 minutes
Cisplatin 1mg/ml	>240	>240 minutes
Etopside (Toposar) 20mg/ml	>240	>240 minutes
Paclitaxel (Taxol) 6mg/ml	>240	>240 minutes
Vincristine Sulfate 1mg/ml	>240	>240 minutes

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for dimensions, thickness, or chemotherapy drug permeation). It references compliance with ASTM standards, which typically define minimum sample sizes for such tests.
Data provenance is not explicitly stated as country of origin, but the submitting company is WRP Asia Pacific Sdn Bhd, located in Malaysia, suggesting the testing might have been conducted there or through certified labs globally. The data appears to be from retrospective testing conducted to demonstrate compliance with established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of device (patient examination glove) does not typically involve human experts to establish "ground truth" in the way a diagnostic imaging AI would. The "ground truth" for the performance tests (like dimensions, physical properties, watertightness, chemical permeation, and sterility) is established by the specified ASTM (American Society for Testing and Materials) and ISO standards. These standards define the test protocols and acceptance criteria, and the results are obtained through objective physical and chemical measurements rather than subjective human interpretation. Therefore, there are no "experts" in the traditional sense of clinical specialists establishing ground truth; rather, qualified laboratory technicians conduct the tests according to the standard protocols.

4. Adjudication method for the test set

Not applicable. As noted above, the "ground truth" is determined by objective measurements against established standards, not by expert consensus or adjudication of subjective interpretations.

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

Not applicable. This is not a diagnostic AI device requiring human reader performance studies. It is a physical medical device (glove) whose performance is evaluated through objective physical and chemical testing.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for all performance characteristics is defined by objective measurements and test methods specified in the referenced ASTM and ISO standards. For example:

Physical properties (Dimensions, Thickness, Physical Properties): Measured values compared against specified ranges in ASTM D6319-00a.
Powder Free: Gravimetric measurement (≤ 2 mg/glove by ASTM D6124-01).
Biocompatibility: In vitro or in vivo tests (e.g., guinea pig maximization test for sensitization) as per ASTM F-720-81, with "Passes" indicating lack of irritation/sensitization.
Watertight: Visual inspection for leaks after filling with water as per ASTM D5151-06 (1000ml), often with an AQL (Acceptable Quality Limit) specified.
Resistance to permeation by Chemotherapy Drugs: Breakthrough time measured using analytical methods (e.g., gas chromatography, liquid chromatography) as per ASTM D6978-05.
Sterility: Dose validation report according to ANSI/AAMI/ISO 11137, confirming a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "device performance" is based on testing batches of manufactured gloves against predefined standards.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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1.0

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Submitter:

K083305

JUN 18 2009

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: Nov 2008

2.0 Name of the device:

Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim

Common Name: Exam Gloves

Classification Name: Patient Examination Gloves, Specialty Chemotherapy (21 CFR 880.6250 product code LZC)

510(K) Number: K083305

3.0 Identification of The Legally Marketed Devices that equivalency is claimed:

Powder-Free Blue Nitrile Examination Glove, Sterile

Company: WRP ASIA PACIFIC SDN BHD 510(k): K993313

4.0 Description of The Device:

Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim meet all the requirements of ASTM standard D6978-05, D5712-0562 and FDA 21 CFR 880.6250.

5.0 Intended Use of the Device:

WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

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510(k) SUMMARY

Summary of the Technological Characteristics of the Device: 6.0

The Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim are summarized with the following technological characteristics compared to ASTM D3578-01E1 or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE(Both Predicate andCurrent)
Dimensions	ASTM D6319-00a(2005) e-1	Meets
Physical Properties	ASTM D6319-00a(2005) e-1	Meets
Thickness	ASTM D6319-00a(2005) e-1	Meets
Powder Free	ASTM D6124-01	Meets≤ 2 mg/glove
Biocompatability	Primary SkinIrritationDermal SensitizationASTM F-720-81	Passes(Not a primary skin irritant)Passes(Not a contact sensitizer)
Watertight (1000ml)	ASTM D5151-06	Passes
*Resistance to permeationby Chemotherapy Drugs	ASTM D6978-05	Meets requirement
Sterile	Gamma Irradiated	Sterile (Dose Validation ReportAttached )

Details and discussions of tests can be found in performance section

*Test Chemical and Concentration	AveragebreakthroughDetection Time(minutes)
*Dacarbazine 10mg/ml	>240
Cyclophosphamide (Cytoxan) 20mg/ml	>240
Doxorubicin Hydrochloride 2mg/ml	>240
*5-Flourouracil 50mg/ml	>240
Cisplatin 1mg/ml	>240
Etopside (Toposar) 20mg/ml	>240
Paclitaxel (Taxol) 6mg/ml	>240
Vincristine Sulfate 1mg/ml	>240

WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

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510(k) SUMMARY

Sterility:

Product is labeled as sterile. .
. Sterilization is achieved through gamma irradiation.
SAL: 10-6 .
Method Used to validate sterilization cycle: Method 1 (ANSI/AAMI/ISO 11137) . Sterilization of healthcare products ~ Radiation sterilization
Radiation dose: Minimum 25kGy, Maximum 45kGy .

Sterilizer: Sterilgamma (M) Sdn Bhd Lot 42, Rawang Integrated Industrial Park 48000 Rawang, Selangor . Malaysia

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 Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

JUN 18 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, Sepang Selangor MALAYSIA 43900

Re: K083305
Trade/Device Name: Powder Free Blue Nitrile Examination Gloves, Sterile with

Chemotherapy Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: June 12, 2009 Received: June 16, 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 (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 vour device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Anthony D. antonber

Susan Runner, D.D.S., M.A. Acting 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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Image /page/5/Picture/0 description: The image shows a logo with the letters "WRP" in bold, sans-serif font. To the left of the letters is a stylized graphic that resembles a "W" formed by three curved, ribbon-like shapes. The logo is black and white, with the graphic having a textured appearance due to the black and white contrast.

Appendix G

WRP Asia Pacific Sdn Bhd

Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSIA

Office +60-3-8706 1486 Facsimile +60-3-8706 1557 Email customer_wrp@wrpworld.com Website www.wrpworld.com

Indications for Use

510(k) Number (if known): K083305

Applicant Name: WRP ASIA PACIFIC SDN BHD

Device Name:

Powder Free Blue Nitrile Examination Gloves, Sterile with Chemotherapy Claim

Indications for Use:

WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

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)

Shula A. Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1

510(k) Number: K083305

Your Partner In Protection"

Regulation Number and Section

§ 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.