The gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Description

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided document:

This document is a 510(k) premarket notification for a medical device, specifically a surgical glove. As such, the "study" described is a set of performance tests designed to demonstrate that the device meets established industry standards and regulatory requirements, thereby proving substantial equivalence to previously marketed devices. It is not a clinical "comparative effectiveness study" or "standalone algorithm performance study" in the typical sense for AI/machine learning devices.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a "DERMAGRIP POWDER FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING)". The acceptance criteria are based on ASTM D 3577-99 (Standard Specification for Rubber Surgical Gloves) and the FDA 1000 ml watertight test.

TEST	Acceptance Criteria (ASTM D 3577-99)	Reported Device Performance (DERMAGRIP Powder Free Latex Surgical Glove, Sterile)
1. Watertightness	GI, AQL 1.5	Pass based on: 1) Single Sampling Plan, GI, AQL 1.5; 2) Multiple Sampling Plan, GII, AQL 2.5
2. Length (mm)
5½	min 245	294
6	min 265	300
6½	min 265	298
7	min 265	309
7½	min 265	291
8	min 265	308
8½	min 265	304
9	min 265	301
3. Palm Width (mm)
5½	70 ± 6	72
6	76 ± 6	77
6½	83 ± 6	83
7	89 ± 6	90
7½	95 ± 6	98
8	102 ± 6	102
8½	108 ± 6	108
9	114 ± 6	114
4. Single Wall Thickness (mm)
Finger	min 0.10	0.27
Palm	min 0.10	0.24
Cuff	min 0.10	0.20
5. Physical Properties
Before Aging:
Tensile Strength (MPa)	min 24	29.58
Ultimate Elongation (%)	min 750	902
Stress at 500% Elongation (MPa)	max 5.5	2.95
After Aging:
Tensile Strength (MPa)	min 18	22.92
Ultimate Elongation (%)	min 560	902

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

The document does not explicitly state the exact sample sizes (number of gloves) for each physical test (length, width, thickness, tensile strength, elongation, stress at 500% elongation). However, for the watertightness test, it mentions "Single Sampling Plan, GI, AQL 1.5" and "Multiple Sampling Plan, GII, AQL 2.5". These are quality control sampling plans defined in standards like ISO 2859-1, which specify sample sizes and acceptance/rejection numbers based on lot size and AQL (Acceptable Quality Level). The specific sample size would depend on the lot size from which the gloves were sampled, which is not provided.

Data Provenance: The testing was conducted by "WRP Specialty Products Sdn Bhd" which is located in Sepang, Selangor Darul Ehsan, MALAYSIA. The data is retrospective in the sense that these tests were performed on manufactured gloves prior to this submission for regulatory clearance.

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

This type of device does not involve human expert interpretation or ground truth establishment in the way AI/ML systems do. The performance data is based on objective physical measurements and standardized test methods (ASTM D 3577-99 and FDA 1000 ml watertight test) performed by laboratory personnel. Therefore, no "experts" in that specific sense were used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of device testing. Adjudication methods (e.g., 2+1) are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement between observers. The tests for this device involve objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This is not a software device or an AI/ML system that would involve human readers interacting with an algorithm. The submission focuses on the physical and chemical properties of a medical device (surgical glove).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done. This is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective physical and chemical measurement standards defined in ASTM D 3577-99 and the FDA 1000 ml watertight test. For example:

Watertightness: Defined by the absence of leaks when subjected to the specified water volume and time.
Dimensions (Length, Palm Width, Thickness): Measured according to standard protocols and compared to specified minimums/ranges.
Physical Properties (Tensile Strength, Elongation, Stress at 500% Elongation): Measured using standardized equipment (e.g., tensile tester) and compared against specified minimums/maximums, both before and after accelerated aging.

8. The Sample Size for the Training Set

Not applicable. This device is not a machine learning model, so there is no concept of a "training set" in this context. The manufacturing process itself (which is subject to Good Manufacturing Practices) can be seen as "training" in a very broad sense, ensuring consistent product quality, but it's not a dataset for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows a partial view of a logo or graphic, with the letters "WDR" prominently displayed in a bold, sans-serif font. Above and to the right of the letters, there is a circular shape with some markings inside, possibly representing a stylized design element. The overall composition is simple and graphic, with a focus on the letters "WDR" as the main visual element.

DEC - 2 1999

WRP Specialty Products Sdn Bhd

ATTACHMENT 3

1 1 2 7 1 3 V

K993214

Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

TEL +60-3-846 2055 FAX +60-3-846 1437 URL www.wroworld.com

CONTACT PERSON : S.K.OOI

510(k) SUMMARY

1. Trade Name : DERMAGRIP POWDER FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING) ( D micro pams or less )
1. Common Name Surgeon's Gloves :
1. Classification Name : Surgeon's Glove

4. Substantial Equivalence :

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.

5. Description of Device :

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.

6. Intended Use of Device :

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Image /page/1/Picture/0 description: The image contains the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, set against a black oval shape. To the right of the logo is the text "WRP Specialty Products Sdn Bhd" in a simple, sans-serif font. There is also a handwritten number "5" in a circle above the logo.

7. Summary of Performance Data :

Performance data of gloves to ASTM D 3577-99 and FDA 1000 ml watertight test.

1 1 2 7 1 3 V

TEST	ASTM D 3577-99	DERMAGRIP Powder FreeLatex Surgical Glove, Sterile(Protein Content Labeling) - referto Attachment 7 of Device TestReport of Compliance
1. Watertight (1000 ml)	GI, AQL 1.5	Pass based on1) Single Sampling Plan, GI,AQL 1.5,2) Multiple Sampling Plan, GII,AQL 2.5
2. Length (mm)Size
5½	min 245	294
6	min 265	300
6½	min 265	298
7	min 265	309
7½	min 265	291
8	min 265	308
8½	min 265	304
9	min 265	301
3. Palm Width (mm)Size
5½	$70 \pm 6$	72
6	$76 \pm 6$	77
6½	$83 \pm 6$	83
7	$89 \pm 6$	90
7½	$95 \pm 6$	98
8	$102 \pm 6$	102
8½	$108 \pm 6$	108
9	$114 \pm 6$	114
4. Single Wall Thickness(mm)
Finger	min 0.10	0.27
Palm	min 0.10	0.24
Cuff	min 0.10	0.20
TEST	ASTM D 3577-99	DERMAGRIP Powder FreeLatex Surgical Glove, Sterile(Protein Content Labeling) - referto Attachment 7 of Device TestReport of Compliance
5. Physical Properties
Before Aging :
Tensile Strength (MPa)	min 24	29.58
Ultimate Elongation (%)	min 750	902
Stress at 500% Elongation(MPa)	max 5.5	2.95
After Aging :
Tensile Strength (MPa)	min 18	22.92
Ultimate Elongation (%)	min 560	902

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Image /page/2/Picture/0 description: The image shows the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font inside of a black oval shape. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd" in a smaller, sans-serif font. Below the company name is the number "1 1 2 7 · 3 V".

8. Substantial Equivalence based on Assessment of Non-Clinical Performance Data

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3577-99.

9. Conclusion

This glove exceeds the ASTM D 3577-99 requirements, and also meet FDA requirements for water leak test on pinhole AQL.

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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 an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Mr. Soo Kang Ooi Manager, Regulatory Affairs/Quality Assurance WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia

K993214 Re : Dermagrip Powder-Free Latex Surgical Glove, Trade Name: Sterile (Protein Content Labeling 50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: September 15, 1999 September 24, 1999 Received:

Dear Mr. Ooi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Ooi

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrícia Cincinato / for

Timothy A. Ulatowski 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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ATTACHMENT 2

Applicant : WRP Specialty Products Sdn. Bhd.

510(k) Number (if known)

DERMAGRIP POWDER FREE LATEX SURGICAL Device Name : GLOVE, STERILE (PROTEIN CONTENT LABELING) (50 micrograms on less)

Indications for Use :

The surgeon's glove is a device made of natural rubber intended to be worn by 1. surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

Dina S. Lin

Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 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).