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

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 document is a 510(k) summary for the WRP COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE. It details the product's specifications and its compliance with relevant standards. 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)	COMFIT Powder Free Blue Nitrile Examination Glove, Sterile - Reported Performance
Watertight (1000 ml)	G-I, AQL 2.5	Pass (Single Sampling Plan, G-I, AQL 2.5; Multiple Sampling Plan, G-II, AQL 4.0)
Length (mm)
- XS	min 220	- (Not reported for XS)
- S	min 220	248
- M	min 230	245
- L	min 230	245
- XL	-	- (Not reported for XL)
Palm Width (mm)
- XS	70 ± 10	- (Not reported for XS)
- S	80 ± 10	84
- M	95 ± 10	94
- L	111 ± 10	106
- XL	-	- (Not reported for XL)
Single Wall Thickness (mm)
- Finger	min 0.08	0.19
- Palm	min 0.08	0.13
Physical Properties: Before Aging
- Tensile Strength (MPa)	min 14.0	25.01
- Ultimate Elongation (%)	min 700	674 (Note: This is an exception to the ASTM standard, as stated in the text.)
Physical Properties: After Aging
- Tensile Strength (MPa)	min 14.0	25.32
- Ultimate Elongation (%)	min 500	649
Residual Powder	Less than 2mg/glove (Implicit from the standard for powder-free gloves)	Less than (Value is cut-off due to poor OCR, but implied to be compliant)

Note: The document explicitly states that the device "meets ASTM Standard D 3578-99 for all properties with the exception of ultimate elongation before the aging test." However, the conclusion later states that the nitrile gloves "meet the requirement of FDA's 1000 ml Watertight Test and ASTM D 3578-99 Standard Specification for tensile strength." It also mentions that "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 fro tensile strength."

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

Sample Size: The document does not explicitly state the sample size for each specific test (e.g., how many gloves were tested for length, thickness, or watertightness). It refers generally to "Performance data of gloves to ASTM D 3578-99 standard and FDA 1000 ml watertight test." and "refer to Attachment 8 of Device Test Report of Compliance" for detailed results.
Data Provenance: The tests were conducted internally by WRP Asia Pacific Sdn Bhd (Malaysia). The tests were performed to comply with ASTIM D 3578-99 and FDA 1000 ml watertight test. The data is retrospective in the sense that it was collected and analyzed as part of the 510(k) submission process, but the tests themselves would have been prospective evaluations of manufactured gloves.

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

This information is not applicable. The "ground truth" for glove performance characteristics is established by objective measurements against predefined international standards (ASTM D 3578-99) and regulatory tests (FDA 1000 ml watertight test), not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where there might be disagreement among reviewers (e.g., in image interpretation studies). For objective physical and performance tests of medical gloves, measurements are taken, and the results are compared directly to the specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI Assistance

This information is not applicable. The device described is a medical glove, not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical medical glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is based on established international standards and regulatory performance requirements. Specifically:
- ASTM D 3578-99 Standard Specification for Rubber Examination Gloves: This standard defines the acceptable physical dimensions, and mechanical properties (tensile strength, ultimate elongation) before and after aging for examination gloves.
- FDA 1000 ml Watertight Test: This is a specific regulatory test to assess the barrier integrity of examination gloves.

8. The Sample Size for the Training Set

This information is not applicable. The device is a manufactured product (medical glove) undergoing performance testing, not a machine learning model that requires a training set. The manufacturing process itself (Good Manufacturing Practices) ensures consistent quality.

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

This information is not applicable for the reasons mentioned in point 8.

Summary

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WRP Asia Pacific Sdn Bhd

K93313

NOV 2 3 1999

BER PRODUCTS (M) SON BHD

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

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

4. Substantial Equivalence :

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 :

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.

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Gloves For All Reasons™

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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 Blue 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 220S min 220M min 230L min 230XL -	-248245245-
3. Palm Width (mm)Size	XS 70 ± 10S 80 ± 10M 95 ± 10L 111 ± 10XL -	-8494106-
4. Single Wall Thickness(mm)FingerPalm	min 0.08min 0.08	0.190.13
TEST	ASTMD 3578-99	COMFIT Powder Free BlueNitrile Examination Glove,Sterile - refer to Attachment 8 ofDevice Test Report ofCompliance
1. Physical Properties
Before Aging :

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Physica

Tensile Strength (MPa)

Ultimate Elongation (%)

Tensile Strength (MPa)

Ultimate Elongation (%)

After Aging :

Residual Powder

BRODUCTS (M) SDN BHD

25.01

674

25.32

649

Less than 2mg/glove

min 14.0

min 700

min 14.0

min 500

Less than

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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 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 fro tensile strength.

Date Summary Prepared : September 22, 1999. (Amended on November 1, 1999)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

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

к993313 Re : Powder-Free Blue Nitrile Examination Glove, Trade Name: Sterile Requlatory Class: I Product Code: LZA Dated: September 29, 1999 Received: October 4, 1999

Dear Mr. Chow:

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 Regulations, Title 21, Parts 800 to 895. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy R. Ulatowski

Timothy A. Ulatowski 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

510(k) Number (if known) : 长993313

COMFIT POWDER FREE BLUE NITRILE EXAMINATION Device Name : GLOVE, STERILE

Indications For Use :

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

R Over-The-Counter Use

L. A. Cutath

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5 . Onk) 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.