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

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the "DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (ASTM D3578-95)	Reported Device Performance (DERMAGRIP Powder Free Latex Examination Glove)
Watertight (1000 ml)	S-4, AQL 4.0	Pass based on: 1) Single Sampling Plan, S-4, AQL 4.0; 2) Multiple Sampling Plan, GII, AQL 4.0
Length (mm)
Size XS	min 220	245
Size S	min 220	255
Size M	min 230	297
Size L	min 230	249
Size XL	-	253
Palm Width (mm)
Size XS	70 ± 10	77
Size S	80 ± 10	81
Size M	95 ± 10	96
Size L	111 ± 10	105
Size XL	-	114
Single Wall Thickness (mm)
Finger	min 0.08	0.36
Palm	min 0.08	0.25
Physical Properties - Before Aging
Tensile Strength (MPa)	min 14	28.63
Ultimate Elongation (%)	min 700	962
Physical Properties - After Aging
Tensile Strength (MPa)	min 14	18.43
Ultimate Elongation (%)	min 500	1007
Powder Content	-	below 2 mg/glove
Protein Content	-	below 50 microgram/gram

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

Sample Size: The document does not explicitly state a specific sample size (e.g., number of gloves tested). However, for the "Watertight" test, it refers to "Single Sampling Plan, S-4, AQL 4.0" and "Multiple Sampling Plan, GII, AQL 4.0". These are sampling plans from quality control standards, which implicitly define sample sizes based on lot size and AQL. The specific sample sizes are not directly provided in the text.
Data Provenance: The tests were conducted by WRP Specialty Products Sdn. Bhd. in Malaysia, as indicated by the company's address. The data is retrospective, as it's a summary of performance data collected prior to the 510(k) submission date of January 12, 1999.

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

This information is not applicable as the device is a patient examination glove and the acceptance criteria are based on objective physical and chemical properties as defined by ASTM standards and FDA watertight test requirements, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

This information is not applicable as the acceptance criteria are based on objective, quantitative measurements against established standards, not on subjective assessments requiring adjudication.

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:

This information is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a medical glove, not an algorithm. The performance evaluation is of the physical product itself.

7. The type of ground truth used:

The "ground truth" for this device is based on objective, quantitative measurements defined by:
- ASTM D3578-95 standard for natural rubber latex patient examination gloves.
- FDA 1000 ml watertight test.
- Specific thresholds for powder content and protein content.

8. The sample size for the training set:

This information is not applicable as the device is a physical product (glove) and not a software or AI model that requires a training set in the conventional sense. The manufacturing process is subject to quality control, which involves sampling, but this is distinct from an AI training set.

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

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

Summary

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4/23/99

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are stacked horizontally, with the "W" on the left, the "R" in the middle, and the "P" on the right. The letters are enclosed within a thick, black, rounded rectangle. The background of the logo is white.

WRP SPECIALTY PRODUCTS SDN BHD

(Company No: 112713-V)

11, Jalan 2, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia. Fax: +60-3-846 1437 & 846 1482 Tel: +60-3-846 2055 & 846 1486

ATTACHMENT 3

KSS1044

CONTACT PERSON : C. H. KHOO

510(k) SUMMARY

DERMAGRIP POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) 50 micro
Examination Gloves 2. Common Name :
1. Classification Name : Patient Examination Glove

4. Substantial Equivalence :

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the reguirements of ASTM standard D3578-95.

5. Description of Device :

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.

6. Intended Use of Device :

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7. Summary of Performance Data :

... ...

Performance data of gloves to ASTM D 3578-95 and FDA 1000 ml watertight test.

TEST	ASTMD3578-95	DERMAGRIP Powder FreeLatex Examination Glove, NonSterile (Protein ContentLabeling) - refer to Attachment9 of Device Test Report ofCompliance
1. Watertight (1000ml)	S-4, AQL 4.0	Pass based on1) Single Sampling Plan, S-4,AQL 4.0,2) Multiple Sampling Plan, GII,AQL 4.0
2. Length (mm)
Size
XSSMLXL	min 220min 220min 230min 230-	245255297249253
3. Palm Width (mm)
Size
XSSMLXL	70 ± 1080 ± 1095 ± 10111 ± 10-	778196105114
4. Single Wall Thickness(mm)
Finger	min 0.08	0.36
Palm	min 0.08	0.25
TEST	ASTMD3578-95	DERMAGRIP Powder FreeLatex Examination Glove,Non Sterile (Protein ContentLabeling) - refer toAttachment 9 of Device TestReport of Compliance
5. Physical Properties
Before Aging :
Tensile Strength (MPa)	min 14	28.63
Ultimate Elongation (%)	min 700	962
After Aging :
Tensile Strength(MPa)	min 14	18.43
Ultimate Elongation(%)	min 500	1007
6. Powder Content	-	below 2 mg/glove
7. Protein Content	-	below 50 microgram/gram

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

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-95.

Protein content tested on recently manufactured and accelerated aging gloves using ASTM D5712 is below 50 microgram/gram.

9. Conclusion

のお洒落

This glove exceeds the ASTM D3578-95 requirements, meet FDA requirements for waterleak test on pinhole AQL and below 50 microgram/gram protein content labeling claim.

Date Summary Prepared : January 12, 1999.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Cheng Hean Khoo Senior Manager, Regulatory/Environmental Management WRP Specialty Products Sdn. Bhd. Lot 11, Janal 2, Kawasan Perusahaan Bander Baru Salak Tingqi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re : K991044 Dermagrip Powder-Free Latex Examination Trade Name: Glove, Non-Sterile (Protein Content Labeling 50 micrograms or less) Requlatory Class: I Product Code: LYY March 26, 1999 Dated: Received: March 30, 1999

Dear Mr. Cheng Hean Khoo:

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. ਸ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in 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.

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Page 2 - Mr. Cheng Hean Khoo

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 regulation (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,

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.

144104 510(k) Number (if known) : __

DERMAGRIP POWDER FREE LATEX EXAMINATION Device Name : STERILE (PROTEIN CONTENT NON GLOVE. LABELING) ( 50 micrograms or Less )

Indications For Use :

10:30:00

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

Chin S. Kim

ivision of Dental, Infection Control. ad Genera! Hospital Devic 510(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.