The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

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

COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the COMFIT Powder Free Nitrile Examination Glove, Sterile, against ASTM D 3578-99 standard and FDA 1000 ml watertight test.

Here’s a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

TEST	Acceptance Criteria (ASTM D 3578-99)	Reported Device Performance (COMFIT Powder Free Nitrile Examination Glove, Sterile)
1. Watertight (1000 ml)	G-I, AQL 2.5	Pass based on: 1) Single Sampling Plan, G-I, AQL 2.5 2) Multiple Sampling Plan, G-II, AQL 4.0
2. Length (mm)
XS	min 220	-
S	min 220	248
M	min 230	250
L	min 230	260
XL	-	-
3. Palm Width (mm)
XS	$70 \pm 10$	-
S	$80 \pm 10$	84
M	$95 \pm 10$	95
L	$111 \pm 10$	104
XL	-	-
4. Single Wall Thickness (mm)
Finger	min 0.08	0.21
Palm	min 0.08	0.14
5. Physical Properties
Before Aging :
Tensile Strength (MPa)	min 14.0	23.88
Ultimate Elongation (%)	min 700	669
After Aging :
Tensile Strength (MPa)	min 14.0	20.48
Ultimate Elongation (%)	min 500	668
6. Residual Powder	Less than 4mg/glove	Less than 2mg/glove

Note: The device did not meet the ultimate elongation before aging criteria (669% vs min 700%). The document later states, "The performance test data of device as shown above indicate that these nitrile gloves meet requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test." However, the conclusion states, "Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength. Our in-house specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength." This implies the tensile strength was the critical parameter for equivalence despite the elongation discrepancy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document does not explicitly state the specific number of gloves tested for each individual parameter (Length, Palm Width, Thickness, Tensile Strength, Elongation, Residual Powder). For the watertight test, it mentions "Single Sampling Plan, G-I, AQL 2.5" and "Multiple Sampling Plan, G-II, AQL 4.0," which are statistical sampling plans, but the exact sample size chosen based on these plans is not specified.
Data Provenance: The tests were conducted by WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The data is retrospective in the sense that the tests were performed on finished products to demonstrate compliance with existing 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 (examination gloves) does not typically involve "experts" in the sense of medical professionals establishing a ground truth for a test set. The ground truth is objective, measurable physical properties defined by the ASTM D 3578-99 standard and the FDA 1000 ml watertight test. The "experts" would be the personnel performing the standardized laboratory tests according to established protocols, likely with relevant certifications or training in materials science or quality control. The document does not specify the number or qualifications of these individuals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in medical imaging or clinical trials where expert consensus is needed to resolve discrepancies. For objective physical testing of gloves against a standard, such adjudication is not applicable. The results are typically quantitative measurements and pass/fail criteria.

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, an MRMC comparative effectiveness study was not done. This type of study relates to diagnostic accuracy and reader performance in interpreting medical data, often with AI assistance. It is not relevant to the physical performance testing of medical gloves.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which is not applicable to a physical medical device like an examination glove. The performance described is of the glove itself.

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

The ground truth used is primarily standardized test criteria and specifications defined by:
- ASTM D 3578-99 Standard Specification for Rubber Examination Gloves
- FDA 1000 ml watertight test
These standards specify the acceptable ranges for physical properties (length, width, thickness, tensile strength, elongation, residual powder) and performance criteria (watertightness).

8. The sample size for the training set:

This concept is relevant for machine learning models. For a physical medical device like an examination glove, there is no "training set" in the computational sense. The manufacturing process is designed for consistency, and quality control samples are taken from production lots.

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

As there is no "training set" in this context, the question is not applicable. The "ground truth" for the device's design and manufacturing is adherence to the established ASTM and FDA standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of WRP Asia Pacific Sdn Bhd, formerly known as Wembley Rubber Products. The image also contains the number K993311 and the date NOV 19 1999. The logo consists of the letters WRP in a black oval shape. The text "WRP Asia Pacific Sdn Bhd" is written in a bold, sans-serif font.

ATTACHMENT 3 (Revised)

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

TEL +60-3-846 1486 FAX +60-3-846 1485/1557 EML mktgwrp@ibm.net URL www.wrpworld.com

CONTACT PERSON : Y. W. CHOW

510(k) SUMMARY

COMFIT POWDER FREE NITRILE EXAMINATION 1. Trade Name : GLOVE, STERILE
Examination Gloves 2. Common Name :
Patient Examination Glove 3. Classification Name :

Substantial Equivalence : 4.

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test.

5. Intended Use of Device :

Page 1 of 3

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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo includes the letters "WRP" in bold, white font inside of a black oval. Below the company name is the text "FORMERLY KNOWN AS WEMBLEY RUBBER PRODUCTS (M) SDN BHD" and the number "1 4 7 8 1 7 V".

6. Summary of Performance Data :

Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test.

TEST	ASTM D 3578-99	COMFIT Powder Free Nitrile Examination Glove, Sterile - refer to Attachment 8 of Device Test Report of Compliance
1. Watertight (1000 ml)	G-I, AQL 2.5	Pass based on1) Single Sampling Plan, G-I, AQL 2.5,2) Multiple Sampling Plan, G-II, AQL 4.0
2. Length (mm)
Size
XS	min 220	-
S	min 220	248
M	min 230	250
L	min 230	260
XL	-	-
3. Palm Width (mm)
Size
XS	$70 \pm 10$	-
S	$80 \pm 10$	84
M	$95 \pm 10$	95
L	$111 \pm 10$	104
XL	-	-
4. Single Wall Thickness(mm)
Finger	min 0.08	0.21
Palm	min 0.08	0.14
TEST	ASTM D 3578-99	COMFIT Powder Free Nitrile Examination Glove, Sterile -refer to Attachment 8 of Device Test Report of Compliance
5. Physical Properties
Before Aging :
Tensile Strength (MPa)	min 14.0	23.88
Ultimate Elongation (%)	min 700	669
After Aging :
Tensile Strength (MPa)	min 14.0	20.48
Ultimate Elongation (%)	min 500	668
6. Residual Powder	Less than4mg/glove	Less than 2mg/glove

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the words "WRP Asia Pacific Sdn Bhd" to the right of the letters. Below the company name, it says "FORMERLY KNOWN AS WEMBLEY RUBBER PRODUCTS (M) SDN BHD" in a smaller font.

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

The performance test data of device as shown above indicate that these nitrile gloves meet requirements of ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation before the aging test.

8. Conclusion

Based on the test results, these nitrile gloves meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength. Our inhouse specifications for tensile strength is minimum 15.5 MPa and test results exceed the in-house specifications and ASTM D 3578-99 requirement for tensile strength.

Date Summary Prepared : September 22, 1999 (Amended on October 27, 1999)

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure or a flame, composed of three curved lines that overlap and flow together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Mr. Yue Wah Chow Head of RA/QA WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia

Re: K993311 Powder-Free Nitrile Examination Glove, Trade Name: Sterile Regulatory Class: I Product Code: LZA September 29, 1999 Dated: October 4, 1999 Received:

Dear Mr. Chow:

We have reviewed your Section 510(k) notification of intent to we have referenced above and we have determined the market the acreatially 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Chow

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 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 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.fdaf.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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ATTACHMENT 2

Applicant : WRP Asia Pacific Sdn. Bhd.

K993311 510(k) Number (if known) :

COMFIT POWDER FREE NITRILE EXAMINATION Device Name : GLOVE, STERILE

Indications For Use :

The patient examination glove is a disposable device intended for medical 1. 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)

Over-The-Counter Use OR

Olin S. Lin

َ ivision Sign-Off) Colsion of Dental, Infection Control, · General Hospital D ಿ(k) Number _

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.