The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.

Device Description

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 3577 - 00	Meets
Physical Properties	ASTM D 3577 - 00	Meets
Freedom from pinholes	ASTM D 3577 - 00, FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 97	< 2 mg/glove
Protein Level	ASTM D 5712 - 95	< 50 µg/g (per glove, implied)
Biocompatibility:
Primary Skin Irritation	Primary Skin Irritation in Rabbits	Passes (Not a primary skin irritant)
Dermal Sensitization	Dermal Sensitization	Passes (Not a contact sensitizer)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test set used for each characteristic. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing was conducted by the manufacturer, WRP Specialty Products Sdn. Bhd. in MALAYSIA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of study (evaluating physical and chemical properties of surgical gloves) does not typically involve human experts establishing a "ground truth" for the test set in the same way clinical diagnostic devices do. The ground truth for these characteristics is established by objective, standardized laboratory measurements against defined ASTM and FDA standards.

4. Adjudication Method

Not applicable. The evaluation relies on objective laboratory tests against pre-defined standards, not human interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study is not applicable to the evaluation of surgical glove physical and chemical properties. This type of study is used for diagnostic devices where human readers interpret medical images or data.

6. Standalone Performance Study

Yes, in a sense. The reported "Device Performance" for each characteristic (dimensions, physical properties, freedom from pinholes, powder-free, protein level, and biocompatibility through skin irritation and dermal sensitization tests) represents the standalone performance of the device as measured against established objective standards. It's an algorithm (or device) only evaluation, as there is no human-in-the-loop performance involved in these specific tests.

7. Type of Ground Truth Used

The ground truth used is based on:

Objective, standardized laboratory measurements: For dimensions, physical properties, freedom from pinholes, powder-free content, and protein level. These are quantitative or qualitative assessments against specific ASTM (American Society for Testing and Materials) standards and FDA regulations.
Biological assay results: For biocompatibility (Primary Skin Irritation in Rabbits and Dermal Sensitization), the ground truth is established by the outcome of standard biological tests indicating whether the material is an irritant or sensitizer.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (surgical glove) and not an AI/ML algorithm that requires a training set. The "design" and "manufacturing process" for such a device are validated through established engineering principles and quality control, rather than through a machine learning training paradigm.

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

{0}------------------------------------------------

510(k) Summary

K014288

Submitter: 1.0

FEB 1 3 2002

Name	:	WRP Specialty Products Sdn. Bhd.
Address	:	Lot 11, Jalan 2, Kawasan Perusahaan 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 : 1st August, 2001

2.0 Contact Person:

Name:	Mr. Mohd Haizan Hussein
Phone No .:	+60 3 8706 9788
Fax No .:	+60 3 8706 5020

3.0 Name of the device:

Trade Name	: Powder Free Polymer Coated Latex Surgical Glove,Sterile with Protein Content Labeling (50 micrograms orless)
Common Name	: Surgeon's Gloves
Classification Name	: Surgeon's Gloves

Identification of The Legally Marketed Device: 4.0

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D 3577 - 00 and FDA 21 CFR 800.20.

5.0 Description of The Device:

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.

{1}------------------------------------------------

6.0 Intended Use of the Device:

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are disposable devices intended for medical purposes that is worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Summary of the Technological Characteristics of the Device: 7.0

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3577 - 00	Meets
Physical Properties	ASTM D 3577 - 00	Meets
Freedom from pinholes	ASTM D 3577 - 00FDA 21 CFR 800.20	Meets
Powder-Free	ASTM D 6124 - 97	< 2 mg/glove
Protein Level	ASTM D 5712 - 95	< 50 $ μg/g $
Biocompatability	Primary Skin Irritation inRabbits	Passes(Not a primary skin irritant)
	Dermal Sensitization	Passes(Not a contact sensitizer)

Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0

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 9.0

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 Dermagrip Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (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.

Page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three horizontal lines extending from its body, suggesting wings or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Mr. Mohd H. Hussein Manager WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor, Darul Ehsan, MALAYSIA

Re: K014288

Trade/Device Name: Dermagrip Powder Free Polymer Coated Latex Surgeon's Gloves, Sterile with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: December 13, 2001 Received: December 28, 2001

Dear Ms. Hussein:

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 vour 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.

{3}------------------------------------------------

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

{4}------------------------------------------------

INDICATIONS FOR USE

Applicant:	WRP Specialty Products Sdn Bhd
510(k) Number (if known):
Device Name:		POWDER FREE POLYMER COATED LATE

POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE, STERILE WITH PROTEIN CONTENT LABELING (50 MICROGRAMS OR LESS)

Indications For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter

Elin S. lin

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).