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 nitrile latex patient examination's glove, 80 LZA, powder free. It meats ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE, based on the provided text:

Acceptance Criteria and Device Performance

TEST	Acceptance Criteria (ASTM D 3578-99)	DERMAGRIP Powder Free Blue Nitrile Examination Glove, Non-Sterile Test Results
1. Watertight (1000 ml)	G-1, 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)		Results for different sizes:
Size XS	min 220	-
Size S	min 220	243
Size M	min 230	244
Size L	min 230	246
Size XL	-	-
3. Palm Width (mm)		Results for different sizes:
Size XS	$70 \pm 10$	-
Size S	$80 \pm 10$	84
Size M	$95 \pm 10$	94
Size L	$111 \pm 10$	104
Size XL	-	-
4. Single Wall Thickness (mm)
Finger	min 0.08	0.22
Palm	min 0.08	0.13
5. Physical Properties
Before Aging:
Tensile Strength (MPa)	min 14.0	22.83
Ultimate Elongation (%)	min 700	534 (Failed to meet this criterion)
After Aging:
Tensile Strength (MPa)	min 14.0	23.25
Ultimate Elongation (%)	min 500	491 (Failed to meet this criterion)
6. Residual Powder	Less than 4mg/glove	Less than 2mg/glove

Study Information

Sample size used for the test set and the data provenance:
- The document does not explicitly state the exact sample size for each test. However, it references a "Device Test Report of Compliance" (Attachment 8, not provided) which presumably contains this level of detail.
- Data Provenance: The tests were conducted by WRP Specialty Products Sdn Bhd, which is based in Malaysia. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a continuous monitoring process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for glove performance tests like these is typically established by adhering to standardized testing methods (e.g., ASTM D 3578-99 and FDA 1000ml watertight test) rather than expert consensus on individual cases. The expertise lies in the certified labs and personnel conducting the tests according to these standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept of "adjudication method" is typically relevant for studies involving human interpretation or subjective assessments. For objective performance tests of physical properties of gloves, there isn't an adjudication process among experts. The results are quantitative measurements against an established standard.
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 is completely irrelevant for a medical device like examination gloves, which do not involve reading or interpretation by human "readers" or AI assistance.
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 is also inapplicable to an examination glove.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on standardized specifications and objective measurements as defined by:
  - ASTM D 3578-99 Standard Specification for Rubber Examination Gloves.
  - FDA 1000 ml watertight test.
- These standards specify the acceptable ranges and minimums for physical properties like dimensions, strength, and integrity (watertightness).
The sample size for the training set:
- This document describes testing of the final product, not the development of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of a physical product doesn't involve training data in that sense.
How the ground truth for the training set was established:
- As there is no training set mentioned or implied for this physical product, this question is not applicable.

Summary

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I'm not sure . . .

Lot 17, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi,

3900 Sepang. Selandor Darul Ehsan

+60-3-846 1437 URL www.wrpworld.com

WRP Specialty Products Sdn Bhd

OCT 15

ATTACHMENT 3 (Revised)

K930750

CONTACT PERSON : C. H. KHOO

510(k) SUMMARY

1. Trade Name DERMAGRIP POWDER FREE BLUE NITRILE : EXAMINATION GLOVE, NON 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 meats ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.

5. Intended Use of Device :

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Gloves For All Reasons™

of the WRD Group of Companie

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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	ASTMD 3578-99	DERMAGRIP Powder Free BlueNitrile Examination Glove, Non-Sterile - refer to Attachment 8of Device Test Report of Compliance
1. Watertight (1000 ml)	G-1, 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	XSmin 220Smin 220Mmin 230Lmin 230XL-	-243244246-
3. Palm Width (mm)
Size	XS$70 \pm 10$S$80 \pm 10$M$95 \pm 10$L$111 \pm 10$XL-	-8494104-
4. Single Wall Thickness (mm)
Finger	min 0.08	0.22
Palm	min 0.08	0.13

Page 2 of 3

Gloves For All Reasons™

a matriber of the WRP Group of Campenias

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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 hexagon. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd", also in a bold, black font. Below the company name is the number 1117184.

TEST	ASTM D 3578-99	DERMAGRIP Powder FreeBlue Nitrile ExaminationGlove, Non Sterile refer toAttachment 8 of Device TestReport of Compliance
5. Physical Properties
Before Aging :
Tensile Strength (MPa)	min 14.0	22.83
Ultimate Elongation (%)	min 700	534
After Aging :
Tensile Strength (MPa)	min 14.0	23.25
Ultimate Elongation (%)	min 500	491
6. Residual Powder	Less than4mg/glove	Less than 2mg/glove

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 ASTM D 3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation.

8. Conclusion

Based on the test results, these nitrile gloves meet the requirement of FDA's 1000ml Watertight Test and ASTM D 3578-99 requirement 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.

Date Summary Prepared : March 25, 1999

(First amendement on August 18, 1999) (Second amendment on October 7, 1999)

Page 3 of 3

Gloves For All Reasons™

of the WRP Group of Companies

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Image /page/3/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-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1999

Mr. Cheng Hean Khoo Sr. Manager, Regulatory/Environmental Management WRP Specialty Products Sdn Bhd Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia

Re : K990750 Trade Name: Dermagrip Powder Free Blue Nitrile Examination Glove, Non Sterile Regulatory Class: I Product Code: LZA Dated: August 19, 1999 Received: August 23, 1999

Dear Mr. 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 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 (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. ਸੋ 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

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Page 2 - Mr. Khoo

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 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,

Susan Punner

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.

K 99075D 510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________

Device Name : DERMAGRIP POWDER FREE BLUE _ NITRILE EXAMINATION GLOVE, NON STERILE

Indications For Use :

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)

Over-The-Counter Use OR

Qien S. Lin

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