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.

Device Description

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less)":

It's important to note that this 510(k) summary is for a medical device (gloves), not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or training set details) are not applicable or not provided in this type of submission.

The document primarily focuses on demonstrating that the gloves meet established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standard / Acceptance Criteria Location	Device Performance
Dimensions	ASTM D 3578 01aE2	Meets
Physical Properties	ASTM D 3578 01aE2	Meets
Freedom from pinholes	ASTM D 3578 - 01aE2 & FDA 21 CFR 800.20	Meets (implicitly, as it states it meets standards and FDA requirements for water leak test on pinhole AQL)
Powder-Free	ASTM D 6124 01	< 2 mg/glove
Protein Level	ASTM D 5712 95	< 50 μg/g
Biocompatibility: - Primary Skin Irritation - Dermal Sensitization	Primary Skin Irritation in Rabbits Dermal Sensitization	Passes (Not a primary skin irritant) Passes (Not a contact sensitizer)

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

Sample Size for Test Set: Not explicitly stated. For medical devices like gloves, testing is typically done on batches, and samples are drawn from these batches according to industrial standards (e.g., AQL levels for pinholes). The document refers to meeting ASTM standards, which would implicitly define the sampling methods and sizes.
Data Provenance: Not specified, but likely from internal testing conducted by WRP Specialty Products Sdn Bhd in Malaysia, given the submitter's location. The biocompatibility tests would generally be conducted by specialized laboratories.
Retrospective or Prospective: Not applicable in the context of device performance testing against standards. The tests are performed on newly manufactured devices.

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

Not Applicable. For medical devices like gloves, "ground truth" is defined by established scientific and engineering standards (e.g., ASTM standards for glove properties, FDA regulations for pinholes, established biological assays for biocompatibility). There isn't a panel of clinical experts establishing ground truth in the same way they would for diagnostic imaging.

4. Adjudication method for the test set:

Not Applicable. Performance is assessed against quantitative metrics and established pass/fail criteria from the standards, not through adjudication by multiple human observers.

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:

No. This is not relevant for the assessment of a medical device like examination gloves. MRMC studies are typically for diagnostic AI algorithms where human interpretation is involved.

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

Not Applicable. This is not an AI algorithm; it's a physical medical device.

7. The type of ground truth used:

The "ground truth" is based on established industry standards and regulatory requirements.
- ASTM D 3578 01aE2: Standard Specification for Rubber Examination Gloves.
- FDA 21 CFR 800.20: Regulations for pinhole testing (water leak test).
- ASTM D 6124 01: Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D 5712 95: Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber Products Using the Modified Lowry Method.
- Biocompatibility Standards: Referring to tests for Primary Skin Irritation and Dermal Sensitization (typically conducted following ISO 10993 series or equivalent guidelines).

8. The sample size for the training set:

Not Applicable. This is a physical device, not a machine learning model, so there is no training set.

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

Not Applicable. As there is no training set for this device.

Summary

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510(k) Summary

K022808.

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

2 1 AUG 2002 Date of Summary Prepared:

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 Microgramsor less)

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a52 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 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 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 Micrograms or less) is summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578 01aE2	Meets
Physical Properties	ASTM D 3578 01aE2	Meets
Freedom from pinholes	ASTM D 3578 - 01aE2FDA 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 RabbitsDermal Sensitization	Passes(Not a primary skin irritant)Passes(Not a contact sensitizer)

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.

10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 3 2002

Mr. V. Nadarajan Manager, QA/RA WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinngi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re: K022808

Trade/Device Name: Dermagrip Powder Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYY Dated: August 21, 2002 Received: August 23, 2002

Dear Mr. 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 Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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INDICATIONS FOR USE

Applicant:

WRP Specialty Products Sdn Bhd

510(k) Number (if known):

K022808

Device Name:

POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE WITH PROTEIN CONTENT LABELING CLAIM (20 MICROGRAMS OR LESS) of Total Wafer
Extractable Profess per gram

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter
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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K022808
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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.