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 also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

Device Description

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

AI/ML Overview

The document describes the acceptance criteria and performance data for "Glovetex Examination Gloves, Powdered Non-Sterile (Protein Content Labeling)".

1. Table of Acceptance Criteria and Reported Device Performance:

TEST	ASTM D 3578 - 99 Acceptance Criteria	In-house Specification for Glovetex Examination Gloves, Powdered, Non-Sterile (Protein Content Labeling) (Acceptance Criteria)	Reported Device Performance (Summary of Performance Data)
Watertight (1000 ml)	G-1 ; AQL 2.5	G-1 ; AQL 1.5	Meets AQL 1.5
Length (mm)
Size S	220 Min.	230 Min.	Meets 230 Min.
Size M	230 Min.	230 Min.	Meets 230 Min.
Size L	230 Min.	230 Min.	Meets 230 Min.
Palm Width (mm)
Size S	$80 \pm 10$	$80 \pm 10$	Meets $80 \pm 10$
Size M	$95 \pm 10$	$95 \pm 10$	Meets $95 \pm 10$
Size L	$111 \pm 10$	$111 \pm 10$	Meets $111 \pm 10$
Thickness (mm)
Palm	0.08 Min.	0.08 Min.	Meets 0.08 Min.
Finger	0.08 Min.	0.08 Min.	Meets 0.08 Min.
Physical Properties.	S-2 ; AQL 4.0	S-2 ; AQL 4.0	Meets S-2 ; AQL 4.0
Before Ageing:
- Tensile Strength (MPa)	14 MPa Min.	21 MPa Min.	Meets 21 MPa Min.
- Ultimate Elongation (%)	700% Min.	700% Min.	Meets 700% Min.
After Ageing:
- Tensile Strength (MPa)	14 MPa Min.	16 MPa Min.	Meets 16 MPa Min.
- Ultimate Elongation (%)	500% Min.	500% Min.	Meets 500% Min.
Powder Content.	-	Below 110 mg/glove	Below 110 mg/glove
Moisture Content.	-	0.8 Max.	0.8 Max.
Protein Content.	-	Below 100 µg/g	Below 100 µg/g (on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95)

Study Proving Device Meets Acceptance Criteria:

The document describes a study based on "Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test." and "Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95".

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

The document does not specify the exact sample size used for the various tests. However, it refers to AQL (Acceptable Quality Level) values for Watertight (AQL 1.5) and Physical Properties (AQL 4.0), which are statistical sampling plans used in quality control. This implies that a sufficient sample size was tested to determine compliance with these AQLs.
Data Provenance: The manufacturing company is listed as PT. WRP Buana Multicorpora in Medan-Labuhan Km 17, INDONESIA. The raw data would originate from their in-house testing facilities in Indonesia. The testing itself is retrospective, as it's a summary of performance data collected after manufacturing for the purpose of regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the document describes performance testing for medical gloves, which relies on standardized physical and chemical tests rather than expert interpretation of medical images or conditions. The "ground truth" here is the objective measurement against the specified ASTM standards and in-house criteria.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., medical image reading) where multiple experts might disagree. For the physical and chemical testing of gloves, objective measurements are taken against predefined criteria, and thus, no expert adjudication is required.

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 described is an examination glove, which is a physical product, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study is not relevant.

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

This information is not applicable. The device is an examination glove, not an algorithm.

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

The ground truth used for this study is based on objective measurements against established industry standards (ASTM D 3578-99, ASTM D 5712-95) and the manufacturer's in-house specifications. This includes physical properties (e.g., tensile strength, elongation, dimensions), chemical properties (e.g., protein content, powder content, moisture content), and performance characteristics (e.g., watertightness).

8. The sample size for the training set:

This information is not applicable. There is no "training set" in the context of testing a physical medical device like an examination glove. The performance data presented are results from testing a manufactured product against predefined specifications.

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

This information is not applicable as there is no training set for this type of device testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for PT WRP Buana Multico. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed in a rounded shape. To the right of the logo is the text "PT WRP Buana Multico", with the last part of the text being partially obscured.

Jalan Jermal, No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

TEL +62-61-642 461 +62-61-642 462 FAX +62-61-642 463 URL www.wrpworld.com

510(K) SUMMARY K9946

1. Trade Name : Glovetex Examination Gloves, Powdered Non-Sterile ( Protein Cont
  (Protein Content Labeling)
  (100 MICROGRAMS or LESS)
1. Common Name : Examination Gloves
  MAY 2 3 2000
1. Classification Name : Patient Examination Glove

4. Substantial Equivalence :

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

ട്. Description of Device :
Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.
1. 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 also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

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7. Summary of Performance Data :

Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test.

	TEST	ASTM D 3578 - 99	In-house Specification for
			Glovetex Examination Gloves,Powdered, Non-Sterile
			( Protein Content Labeling )
1.	Watertight (1000 ml)	G-1 ; AQL 2.5	G-1 ; AQL 1.5
2.	Length ( mm)
	SizeXS
	S	220 Min.	230 Min.
	M	230 Min.	230 Min.
	L	230 Min.	230 Min.
	XL
3.	Palm Width (mm)
	SizeXS
	S	$80 \pm 10$	$80 \pm 10$
	M	$95 \pm 10$	$95 \pm 10$
	L	$111 \pm 10$	$111 \pm 10$
	XL
4.	Thickness (mm)
	Palm	0.08 Min.	0.08 Min.
	Finger	0.08 Min.	0.08 Min.
5.	Physical Properties.Before Ageing :	S-2 ; AQL 4.0	S-2 ; AQL 4.0
	- Tensile Strength (MPa)	14 MPa Min.	21 MPa Min.
	- Ultimate Elongation (%)	700% Min.	700% Min.
	After Ageing :
	- Tensile Strength (MPa)	14 MPa Min.	16 MPa Min.
	- Ultimate Elongation (%)	500% Min.	500% Min.
6.	Powder Content.	-	Below 110 mg/glove
7.	Moisture Content.	-	0.8 Max.
8.	Protein Content.	-	Below 100 µg/g

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

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578 - 99.

Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95 below 100 µg/g.

9. Conclusion.

The gloves that is to be marketed meets all the requirements of ASTM D 3578-99 and has a low detectable level of protein ( of about < 100 µg/g ).

Summarised on : December 21st, 1999

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text is black against a white background.

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head and neck, with three lines representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Ng Poy Sin General Manager PT. WRP Buana Multicorpora Jalan Jermal, No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

K994426 Re : Glovetex, Examination Gloves, Powdered Non-Trade Name: Sterile (Protein Content Labeling 100 Microgram or Less) Requlatory Class: I Product Code: LYY Dated: April 24, 2000 April 28, 2000 Received:

Dear Mr. Ng Poy Sin:

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, Druq, 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 aqainst 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. ਜੋ 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 requlatory 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

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Page 2 - Mr. Ng Poy Sin

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.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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INDICATIONS FOR USE

510 (k) Number (if known) :	K994426
Device Name :	Glovetex Latex Examination Glove, PowderedNon-Sterile ( Protein Content Labelling )(100 MICROGRAMS OR LESS)

Indication For Use :

1. The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.
  (Division Sign-Off
  Concurance of CDRH, Office of Device Evaluation (ODE)
  ul Infection Control,

(Division Sign-Orion Infection Control, Division.
and General Hospital De 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counte Use

e
∇

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.