A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners that require a sterile procedure.

A latex examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners that require a sterile procedure.

Device Description

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AI/ML Overview

This document is a 510(k) Summary for Latex Examination Gloves, Pre-powdered. It outlines the device's technical characteristics and performance data to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, structured to address your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ASTM D 3578-95, a standard for Latex Examination Gloves. The reported device performance indicates compliance with these standards.

Characteristic	Acceptance Criteria (ASTM D 3578-95)	Reported Device Performance
Dimensions
Length (XS, S, M, L, XL)	≥ 240 mm	240 mm for all sizes (XS, S, M, L, XL)
Width (XS)	< 80 mm	< 80 mm
Width (S)	80 ± 10 mm	80 ± 10 mm
Width (M)	95 ± 10 mm	95 ± 10 mm
Width (L)	111 ± 10 mm	111 ± 10 mm
Width (XL)	> 111 mm	> 111 mm
Thickness (Cuff)	≥ 0.10 mm	0.10 mm (min)
Thickness (Palm)	≥ 0.10 mm	0.10 mm (min)
Thickness (Finger Tip)	≥ 0.10 mm	0.10 mm (min)
Physical Properties (Before Ageing)
Tensile Strength	21 Mpa (min)	21 Mpa (min)
Ultimate Elongation	700 % (min)	700 % (min)
Physical Properties (After Ageing at 100°C 22 hrs)
Tensile Strength	16 Mpa (min)	16 Mpa (min)
Ultimate Elongation	600 % (min)	600 % (min)
Performance Requirements (AQLs)
Visible Defects (Stains, Lumps, Holes etc.)	AQL 2.5 (Inspection Level S-4)	Meets AQL 2.5
Watertight (Holes)	AQL 1.5 (Inspection Level S-4)	Meets AQL 1.5 (Meets FDA pinhole requirement)
Dimensions (Width, Length & Thickness)	AQL 4 (Inspection Level S-2)	Meets AQL 4
Physical Properties (Before and after ageing)	AQL 4 (Inspection Level S-2)	Meets AQL 4
Sterility (Fails sterility)	Not Acceptable	Meets the sterility assurance level

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

The document does not explicitly state the numerical sample sizes for each test (e.g., number of gloves tested for dimensions, watertightness, etc.). However, it refers to "Inspection Level S-4" and "S-2" for various performance requirements, which are standard sampling plans defined in relevant quality control regulations (likely ISO 2859 or military standards for sampling by attributes). These levels imply specific sample sizes will be drawn based on the batch size, but the exact number isn't provided here.

Data Provenance: The manufacturing company is PT. Maja Agung Latexindo, located in Sumatera Utara, Indonesia. The tests were performed to meet the ASTM D 3578-95 standard, an international standard. The data itself is likely generated internally by the manufacturer during quality control processes. It is retrospective data, as it describes the performance of already manufactured gloves.

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

This type of medical device (latex examination gloves) does not typically involve human experts to establish "ground truth" for performance tests in the same way an AI diagnostic algorithm might. The "ground truth" for these tests is defined by objective, measurable parameters (e.g., physical dimensions, tensile strength, absence of holes) as specified in the ASTM D 3578-95 standard. The tests are conducted using standardized methods and equipment. Therefore, there's no mention of experts establishing ground truth in terms of clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for these tests is objective and quantitative, defined by the ASTM standard. There would be no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for comparing the diagnostic performance of human readers, often with and without AI assistance, especially in image interpretation. This document pertains to the physical and mechanical properties of medical gloves, not a diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.

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

Yes, in a sense. The "device" in this context is the physical latex glove. Its performance is evaluated directly through various laboratory tests (dimensional measurements, tensile strength tests, water leak tests, sterility tests) without human intervention in the interpretive phase (except for performing the tests and recording results). There is no "algorithm" involved in the performance testing of these gloves as there would be for an AI-powered device.

7. The Type of Ground Truth Used

The ground truth used is based on objective, quantitative measurements and adherence to established performance standards (ASTM D 3578-95). For example:

Dimensions: Measured values compared against specified ranges.
Physical Properties: Measured tensile strength and elongation compared against minimum requirements.
Watertightness: Absence of holes determined by a water leak test, conforming to FDA pinhole requirements.
Sterility: Absence of microbial growth, conforming to sterility assurance levels.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product (latex gloves), not an artificial intelligence model or algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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FEB

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PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 859 62-61 - 859 Fax. 62-61 - 859

Page Numbers 1 of 2

K 994255

"510 (K)" SUMMARY

(1) Name of applicant	: Mr. Hansen Laurence
Address	: PT.Maja Agung LatexindoJI.H. M. Yamin No. 40-40 AMedanIndonesia
Phone No.	62-61-328888; 62-61-859170
Fax No.	62-61-520588; 62-61-520588

The contact persons within the firm as well as in U.S.A are given below.

Contact person in firm	: Mr. Hansen LaurenceFax No.: 62-61-520588 62-61-8459180
Contact person in U.S.A	: Emmy TjoengFax No.: 626-913-1498

(2) Device details
Trade Name	: Private lebel-Latex Examination Gloves Pre - Powdered
Classification Name	: Patient Examination Gloves
Product Code	: Latex 80 LYY

(3) Equivalent device legally marketed	: Class I Latex Examination Gloves 80 LYYPre-Powdered meeting ASTM D 3578-95
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(4) Intended use	: A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners that require a sterile procedure.
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Image /page/1/Picture/0 description: The image shows a stylized logo with the letters "Ma" in a cursive font. The letters are bold and black, contrasting with the white background. Horizontal lines run across the top portion of the logo, creating a striped effect behind the letters. The bottom left corner of the logo is filled with a solid black square, providing a visual anchor and adding depth to the design.

PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

OF LATEX GLOVES

Telp. 62-61 - 85916 62-61 - 85917 Fax. 62-61 - 85918

Page Numbers 2 of 2

Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

	(5) Technological characteristic of the Gloves.
a.	DimensionsSizes	XS	S	M	L	XL
	Length	240 mm	240 mm	240 mm	240 mm	240 mm
	Width	80 < mm	80±10 mm	95±10 mm	111±10 mm	>111mm
	Thickness
	1. Cuff (min)	0.10 mm	0.10 mm	0.10 mm	0.10 mm	0.10 mm
	2. Palm (min)	0.10 mm	0.10 mm	0.10 mm	0.10 mm	0.10 mm
	3. Finger Tip (min)	0.10 mm	0.10 mm	0.10 mm	0.10 mm	0.10 mm
b.	Physical Properties
		Before ageing			After ageingat 100°C 22 hrs.
	Tensile StrengthUltimate Elongation		21 Mpa (min.)700 % (min.)		16 Mpa (min.)600 % (min.)
c.	Performance Requirement
	Characteristic	Related Defects		InspectionLevel		AQL
	Visible defects	Stains, Lumps,Holes etc.		S-4	2.5
	Watertight	Holes		S-4	1.5
	Dimensions	Width Length& Thickness		S-2	4
	Physical Properties	Before andafter ageing		S-2	4
	Sterility		Fails sterility			Not Acceptable

(6) Performance data is the same as mentioned immediately above.
(7) Clinical date is not needed for Gloves or for most devices deared by the 510 (K) process.
(8) Non-dinical data Gloves meet or exceed the ASTM D 3578 Standard. Meets FDA pin hole requirement. Meets labeling daim. Meets the sterility assurance level.

રેર

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ANNEXURE XI

: 上一篇:

۲۰۰:

MATERIALS USED FOR THE PRODUCTION OF LATEX EXAMINATION GLOVES - PRE-POWDERED

	Dry Weight
60 %Concentrated Natural Rubber Latex	- 100
Zinc diethyl dithiocarbamate	- 0.50
Zinc dibutyl dithiocarbamate	- 0.30
Zinc oxide	- 0.75
Sulphur	- 0.80
KOH Solution	- 0.10
Titanium dioxide	- 0.60
BHT	- 1.50

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

PT. Maja Agung Latexindo c/o Mr. Emmy Tjoeng Official Correspondent for PT. Maja Aqunq Latexindo Shamrock Marketing Company, Incorporated 889 South Azusa Avenue City of Industry, California 91748

Re : K994255 Latex Examination Gloves Pre-powdered Trade Name: Sterile Requlatory Class: I Product Code: LYY December 15, 1999 Dated: December 17, 1999 Received:

Dear Mr. Tjoeng:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ರ್ಥ 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. Tjoeng

the Federal Register. Please note: this response to your premarket notification submission does not affect any premailor 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 marketou production overmits 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

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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Image /page/5/Picture/0 description: The image shows a logo with the letters 'Ma' in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background consists of horizontal lines, creating a striped effect behind the letters. A solid black block is positioned to the left of the letters, adding a contrasting element to the design.

PT. MAJA AGUNG LATEXIND

MANUFACTURING OF LATEX GLOVES

Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 85 62-61 - 85 Fax. 62-61 - 85

ANNEXURE II

K994255

INDICATION FOR USE

Applicant Device Name : Mr. Hansen Laurence : Latex Examination Gloves Pre-Powdered Sterile

Indication for use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

P.T. Julia Aguing

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcc 21 CFR 801.109)

Over-The-Counter Use X

(Optional Format 1-2-96)

Qain S. Lin

Division of Dental, Infection Cont

(Division Sign-Off)

and General Hospita 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.