The 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.
The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Device Description

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Dermagrip Powder Free Latex Examination Gloves" based on the provided 510(k) summary:

This device is a medical glove, and the studies performed are for validating performance characteristics against established ASTM (American Society for Testing and Materials) and FDA standards, not for evaluating an AI algorithm's diagnostic performance. Therefore, many of the requested categories related to AI studies (e.g., sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable to this type of device and study.

Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 3578 – 01EI	Meets
Physical Properties	ASTM D 3578 – 01EI	Meets
Freedom from pinholes	ASTM D 3578 – 01EI FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 – 01	< 2 mg/glove
Protein Level	ASTM D 5712 – 95	< 50 µg/g
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation in Rabbits (Test)	Passes (Not a primary skin irritant)
Biocompatibility: Dermal Sensitization	Dermal Sensitization (Test)	Passes (Not a contact sensitizer)
Resistance to permeation by commonly used chemotherapy drugs	ASTM F 739 – 99a	Passes

Study Information (Non-AI Device)

Sample size used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes for each test in terms of number of gloves or specific batches. However, compliance with ASTM and FDA standards implies that appropriate sample sizes would have been used as specified by those standards for each particular test (e.g., AQL for pinholes, multiple specimens for physical properties).
- Data Provenance: Not explicitly stated, but the submission is from a Malaysian company (WRP Specialty Products Sdn Bhd), so the testing would likely have been conducted in line with international standards recognized by that region and the U.S. FDA. The testing is performed on the device itself rather than patient data, so "country of origin of the data" in a patient context is not applicable. The studies are prospective in the sense that they are performed on manufactured product to demonstrate compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is for a non-AI medical device (gloves). Ground truth is established by objective physical, chemical, and biological tests governed by the specified ASTM and FDA standards, not by expert consensus on interpretations of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is for a non-AI medical device. The results are determined by adherence to standardized test methods and criteria, not by human adjudication of interpretations.
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 for a non-AI medical device. No MRMC study was performed as no "readers" or "AI assistance" are involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for a non-AI medical device. No algorithm is involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective measurement against specified performance criteria defined by internationally recognized standards (ASTM) and regulatory requirements (FDA). This includes:
  - Physical measurements: (e.g., dimensions, force at break for physical properties).
  - Chemical analysis: (e.g., protein content, residual powder count).
  - Biological testing: (e.g., primary skin irritation, dermal sensitization in animal models).
  - Permeation testing: (e.g., breakthrough time for chemotherapy drugs).
The sample size for the training set:
- Not applicable. As a non-AI device, there is no "training set" in the machine learning sense. The tests are performed on representative samples of the manufactured gloves.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm.

Summary

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JUN 1 0 2002

K021536

510(k) Summary

1.0 Submitter:

. . . .

Name:	WRP Specialty Products Sdn Bhd.
Address:	Lot 11, Jalan 2, Kawasan Perushaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:	+60 3 8706 9788
Fax No.:	+60 3 8706 5020

Date of Summary Prepared: 08 MAY 2002

2.0 Contact Person:

Name:	V. Nadarajan
Phone No.:	+60 3 8706 9788
Fax No.:	+60 3 8706 5020

3.0 Name of the device:

Proprietary or Trade Name:	1) Dermagrip, and2) Multiple or Customer's Trade Name
Classification Name:	Patient Examination Gloves (per 21 CFR 880.6250)
Device Name:	Powder Free Latex Examination Gloves, Non-Sterilewith Protein Content Labeling Claim (50 Microgramor less) and Tested for Use with Chemotherapy Drugs

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LY, powder free, that meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with_Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

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6.0 Intended Use of the Device:

The 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.

7.0 Summary of The Technological Characteristics of The Device:

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs is summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578 – 01EI	Meets
Physical Properties	ASTM D 3578 – 01EI	Meets
Freedom from pinholes	ASTM D 3578 – 01EIFDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 – 01	< 2 mg/glove
Protein Level	ASTM D 5712 – 95	< 50 µg/g
Biocompatability	Primary Skin Irritation in Rabbits	Passes(Not a primary skin irritant)
	Dermal Sensitization	Passes(Not a contact sensitizer)
Resistance topermeation bycommonly usedchemotherapy drugs	ASTM F 739 – 99a	Passes

8.0 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.

9.0 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.

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Conclusion 10.0

It can be concluded that the Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs will perform according to the glove performance standards referenced in Section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. V. Nadarajan WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan B Baru Salak, Tinggi 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K021536

Trade/Device Name: Dermagrip and Multiple Powder Free Latex Examination Gloves with Protein Labeling Claim ( 50 Micrograms or Less ) and Tested for Use with Chemotherapy Drugs Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 8, 2002 Received: May 10, 2002

Dear Mr. V. Nadarajan:

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 such 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. Nadarajan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internetaddress http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant:	WRP Specialty Products Sdn Bhd
510(k) Number (if known):	K021536
Device Name:	POWDER FREE LATEX EXAMINATIONGLOVES, NON STERILE WITH PROTEINCONTENT LABELING CLAIM (50MICROGRAM OR LESS) AND TESTED FORUSE WITH CHEMOTHERAPY DRUGS

Indications For Use:

The patient examination glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter

Qium Si Lin,

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 10 2

Page 1 of 1

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.